Company ยท US
Nurse Assist, Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2008 to 2020. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
64recalls (0 in 12 months)
21recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 11, 2020 | K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe f Nurse Assist, LLC | NGT |
| Aug 31, 2015 | K150143 | Normal Saline Flush Nurse Assist, Inc. | NGT |
| Aug 10, 2012 | K121390 | LUBE JELLY SURINGE Nurse Assist, Inc. | KMJ |
| Dec 18, 2008 | K083042 | WOUND FLUSH, STERILE WATER & NORMAL SALINE Nurse Assist, Inc. | FRO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2023 | Nurse Assist, LLC Sterile Water: Product Name/Product Code: USP STERILE WATER SYRINGE/1030A, SYRINGE PREFILLED 10 ML/6496722, 30CC PREFILLED SYRINGE/6496723, USP STERILE WATER SYRINGE/1030, 10CC PREFILLED SYRINGES/5163 Open, Classified |
EZL | K030813 |
| Dec 20, 2023 | Nurse Assist, LLC Sterile Water/Saline: Product Name/Product Code: CUP STERILE WATER FOIL LID 120 ML/T167005; CUP STERILE SALINE FOIL LID 120 ML/T167007 Open, Classified |
FRO | None listed |
| Dec 20, 2023 | Nurse Assist, LLC Sterile Water/Saline: Brand Name: Product Name/Product Code:
CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/ Open, Classified |
FRO | K083042 |
| Dec 20, 2023 | Nurse Assist, LLC 0.9% Sodium Chloride: Product Name/Product Code: 10ML IV FLUSH STERILE FIELD/EMZ10091240 Open, Classified |
NGT | K201286 |
| Dec 20, 2023 | Nurse Assist, LLC 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-B Open, Classified |
NGT | K030813 K083042 +1 |
| Jan 3, 2017 | Nurse Assist, Inc Normal Saline Flush 0.9% USP Sodium Chloride Injection Syringe, 3 ml fill, 5 ml fill and 10 ml fill. Product codes: 1203, 1205, 1210, 1210-BP
Product usage: Saline flush Terminated |
NGT | K150143 |
| Jan 11, 2012 | Nurse Assist, Inc REF UT8150 Urethal Insertion Tray 14Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERI Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc REF UT8140 Urethal Insertion Tray Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Mi Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERI Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERI Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 8012 (STERILE) CATHETER CARE KIT 60 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com
CATHETER CARE KIT Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7402 (STERILE) URETHRAL CATHETER KIT (Female) 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com
URETHRAL Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7401 (STERILE) URETHRAL CATHETER KIT With 3 Compartment Plastic Pouch. LOT 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 w Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7305 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 ww Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7304 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 ww Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7303 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 ww Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7302 (STERILE) URETHRAL CATHETER TRAY w/ Red Rubber Catheter Caution: Contains Natural Latex 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7301 (STERILE) URETHRAL CATHETER TRAY w/ Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.co Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc WELCON TM BRAND REORDER NO. 7300 (STERILE) URETHRAL CATHETER TRAY w/o Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.c Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc McKESSON Medi-Pak Foley Catheter Tray without Catheter For Use With 30 cc Foley Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed by McKesson Corporation Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc McKESSON Medi-Pak Urethral Catheter Tray with Red Rubber Catheter Sterile.Single Use.Disposable 20 Trays Per Case Reorder No. 37-232 CAUTION: THIS PRODUCT CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE Terminated |
KOD | K830359 |
| Jan 11, 2012 | Nurse Assist, Inc McKESSON Medi-Pak Urethral Catheter Tray with Plastic Catheter Sterile.Single Use.Disposable.Latex-Free 20 Trays Per Case Reorder No. 37-231 Marketed by McKesson Corporation McKesson Medical-Surgical, Terminated |
KOD | K830359 |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT8155 Urethal Insertion Tray 14 Fr Red Rubber Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S 30 Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT8150 Urethral Insertion Tray 14 Fr Red Rubber Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. STERILE EO Manufactured for: Coloplast A/S Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT 8145 Urethral Insertion Tray 14Fr Nelaton PVC Catheter with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Colo Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: UT8140 Urethral Insertion Tray 14 Fr Nelaton PVC Catheter with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplas Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT7035 Catheter Insertion Tray 30cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Colopla Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplas Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT7015 Catheter Insertion Tray 10cc Pre-Filled Syringe with BZK Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplas Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REF UT7010 Catheter Insertion Tray 10cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Manufactured for: Colop Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7504 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern C Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7503 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern C Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7502 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber Catheter includes BZK Swabsticks Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-6 Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7501 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic Catheter includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7500 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/o Plastic Catheter includes BZK Swabsticks nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. For Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7402 (STERILE) WELCON BRAND URETHRAL CATHETER KIT (Female) nurse assist incorporated 25 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com
Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc REORDER NO. 7305WTU (NON-STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe this product is intended to be sterilized by the end processor nurse assist incorporated 20 Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7305 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, T Terminated |
FCM | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7304 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7303 (STERILE) WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, T Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7302 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber Catheter Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7301 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic Catheter nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurs Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7300 (STERILE) WELCON BRAND URETHRAL CATHETER TRAP w/o Plastic Catheter nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nur Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7204 (STERILE) CSR WRAP WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe nurse assist incorporated 20 ex/Box 800-649-6800 3400 Northern Cross Blvd. Fort Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7203 (STERILE) CSR WRAP WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/10ml. Prefilled Syringe 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurse Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7202 (STERILE) CSR WRAP WELCON BRAND URETHRAL CATHETER TRAY with 14 french red rubber catheter Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-680 Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7201 (STERILE) CSR WRAP WELCON BRAND URETHRAL CATHETER TRAY w/ Plastic Catheter anureses assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76 Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: REORDER NO. 7200 (STERILE) CSR WRAP WELCON BRAND URETHRAL CATHETER TRAY w/o Catheter nurse assist incorporated 20 ex/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nu Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: McKESSON Medi-Pak LATEX FREE Foley Catheter Tray Without Catheter For Use With 30 cc Foley Catheter Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-234 Marketed Terminated |
KOD | None listed |
| May 25, 2011 | Nurse Assist, Inc Case Label: McKESSON Medi-Pak Ureteral Catheter Tray With Red Rubber Catheter Sterile Single Use Disposable 20 Trays Per Case Reorder No. 37-232 Marketed By McKesson Corporation McKesson Medical-Surg Terminated |
KOD | None listed |
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