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Panels › General Hospital › Product code NZW · Class 2

Heparin, Vascular Access Flush

Regulation 880.5200

0510(k)s in 12 months (7 all time)
0recalls in 12 months (44 all time)
27recalls that name a 510(k)
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Top companies in NZW

DateFirm and productCodeLinked 510(k)
Aug 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
Excelsior Heparin Sodium, Porcine, Preservative Free 100 U / mL Solution Prefilled Syringe, Partial Fill 5 mL Fill in 10 mL Syringe Model Number: 513604
Open, Classified
NZWK133446
Jun 14, 2016Excelsior Medical Corp
Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.
Terminated
NZWK023740
Jan 29, 2015Fresenius Kabi USA, LLC
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
Terminated
NZWK092938
Mar 6, 2014Medefil Incorporated
Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes, 100 units/mL, 3 mL fill in a 12 mL syringe.
Terminated
NZWK092491
Jun 19, 2012App Pharmaceuticals Llc
HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-544-01, Product Code 504401, Rx only To maintain patency of an indwelling venipunc
Terminated
NZWNone listed
Jun 19, 2012App Pharmaceuticals Llc
HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL, NDC 63323-545-01, Product Code 504501; and HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/m
Terminated
NZWNone listed
Jun 13, 2012Vygon Corporation
Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter l
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter l
Terminated
NZWK061497
Jun 13, 2012Vygon Corporation
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Terminated
NZWK061497
Jun 5, 2012Excelsior Medical Corp
Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR Excelsior Medical Neptune, NJ 07753 (800) 487-4276 Made in USA NDC 63807060055. Used to maintain
Terminated
NZWK061497
Dec 10, 2010Medefil Incorporated
Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V.
Terminated
NZWK092491
Dec 10, 2010Medefil Incorporated
Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V.
Terminated
NZWK092491
Dec 10, 2010Medefil Incorporated
Medefil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V
Terminated
NZWK092491
May 9, 2008Medefil Incorporated
Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. F
Terminated
NZWNone listed
May 9, 2008Medefil Incorporated
Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V.
Terminated
NZWNone listed
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 100UlmL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881591125, Tyco Healthcare, Mansfield, MA 02048
Terminated
NZWK032438
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe 5mL REF # 8881590125, Tyco Healthcare, Mansfield, MA 02048
Terminated
NZWNone listed
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 3rnL REF # 8881590123, Tyco Healthcare, Mansfield, MA 02048
Terminated
NZWK032438
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe 10mL REF # 8881590121, Tyco Healthcare, Mansfield, MA 02048
Terminated
NZWK032438
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL, with BLUNTIP plastic cannula REF # 8881581125, Tyco Healthcare, Mansfield, MA 02048
Terminated
NZWK032438
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 10U/mL Heparin Lock Flush Syringe 2.5mL in 3mL syringe REF # 8881580300, Tyco Healthcare, Mansfield, MA 02048
Terminated
NZWK032438
May 9, 2008Covidien LP
Tyco Healthcare Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe 5mL REF # 8881580125Tyco Healthcare, Mansfield, MA 02048
Terminated
NZWK032438
May 9, 2008Covidien LP
Tyco HealthcareMonoject Prefill 10U/mL Heparin Lock Flush Syringe, 3mL REF # 8881580123, Tyco Healthcare, Mansfield, MA 02048
Terminated
NZWK032438
May 9, 2008Covidien LP
Tyco Healthcare Monoject Prefill 10U/rnL Heparin Lock Flush Syringe, 10ml, REF # 8881580121, Tyco Healthcare, Mansfield, MA 02048
Terminated
NZWNone listed
May 9, 2008Medefil Incorporated
Medifil Heparin I.V. Flush Syringe 100 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V
Terminated
NZWNone listed
Apr 4, 2008Baxter Healthcare Corp.
Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack, NDC 0641-0273-25 (NDC 0641-0273-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
NZWNone listed
Apr 4, 2008Baxter Healthcare Corp.
Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 10 units/mL-1 mL vial, 25 pack, NDC 0641-0272-25 (NDC 0641-0272-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
NZWNone listed
Apr 4, 2008Baxter Healthcare Corp.
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-30 mL vial, 25 pack, NDC 0641-2443-45, (NDC 0641-2443-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
NZWNone listed
Apr 4, 2008Baxter Healthcare Corp.
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC 0641-2436-45, (NDC 0641-2436-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
NZWNone listed
Apr 4, 2008Baxter Healthcare Corp.
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack , NDC 0641-0389-25, (NDC 0641-0389-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
NZWNone listed
Apr 4, 2008Baxter Healthcare Corp.
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC 0641-0387-25, (NDC 0641-0387-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
NZWNone listed
Apr 4, 2008Baxter Healthcare Corp.
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 units/mL-30 mL vial; 25 pack, NDC 0641-2442-45 (NDC 0641-2442-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
NZWNone listed
Apr 4, 2008Baxter Healthcare Corp.
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25 pack, NDC 0641-2438-45, (NDC 0641-2348-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
NZWNone listed
Apr 4, 2008Baxter Healthcare Corp.
Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 u/mL-2 mL vial, 25 pack, NDC-0641-0393-25, (NDC-0641-0393-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
NZWNone listed
Apr 4, 2008Baxter Healthcare Corp.
Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC 0641-0392-25 (NDC 0641-0392-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015
Terminated
NZWNone listed

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