Panels › General Hospital › Product code KMJ · Class 1
Lubricant, Patient
Regulation 880.6375
0510(k)s in 12 months (49 all time)
0recalls in 12 months (17 all time)
5recalls that name a 510(k)
Top companies in KMJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Apogee Medical | 0 | 7 |
| Span-America Medical Systems, Inc. | 3 | 0 |
| Abco Dealers, Inc. | 2 | 0 |
| Biofilm, Inc. | 2 | 0 |
| General Medical Co. | 2 | 0 |
| Osbon Medical Systems, Ltd. | 2 | 0 |
| Pediatric Pharmaceuticals, Inc. | 2 | 0 |
| Teleflex Medical | 0 | 2 |
| A.D.T. Lab Industries | 1 | 0 |
| American Medical Systems, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office DYNAREX DynaLube LUBRICATING JELLY, STR 2.7GM (144/BX 12BX/CS)
Catalog #1250 Open, Classified |
KMJ | K092488 |
| Dec 12, 2016 | MEDLINE IND Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml).
Product Usage:
For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeuti Terminated |
KMJ | K041060 |
| May 20, 2016 | Amerx Health Care Corp. Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz. Terminated |
KMJ | K970133 |
| Jul 20, 2012 | Westone Laboratories, Inc. Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles.
Product Usage:
The product is used as a patient lubri Terminated |
KMJ | None listed |
| May 12, 2011 | Eli Lilly and Company Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guide Terminated |
KMJ | None listed |
| Apr 18, 2011 | DeRoyal Processing Center Lubricating Jelly packaged as follows:
(1) DeRoyal(R) Water Soluble Lubricant, Size: 5 Gram, Rx Only, REF 31-702, STERILE EO, Distributed by: DeRoyal - 200 DeBusk Lane, Powell, TN 37849, USA;
(2 Terminated |
KMJ | K871169 |
| Apr 13, 2011 | Cardinal Health Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; Packaged by Cardinal Health Medical Products and Services, McGaw Park Terminated |
KMJ | None listed |
| Apr 5, 2011 | Teleflex Medical Rusch Irrigation Tray w/Bulb Catalogue Number 68895
For irrigation according to institutional guidelines. Terminated |
KMJ | None listed |
| Apr 5, 2011 | Teleflex Medical Rusch Irrigation Tray w/Piston Catalogue Number 67890
For irrigation according to institutional guidelines. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Small, Vinyl, REF: 6116, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Medium, Vinyl, REF: 6115, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Large, Vinyl, REF: 6114, Apogee Medical, LLC, 90 Weathers Street, Bournesville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Small, Latex, REF: 6113, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Medium, Latex, REF: 6112, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Irrigation Kit, Large, Latex, REF: 6111, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheterizations. Terminated |
KMJ | None listed |
| Feb 3, 2011 | Apogee Medical Catheter Insertion Kit, REF: 6100A, Latex Free, Sterile, Apogee Medical, LLC, 90 Weathers Street, Youngsville, NC 27596.
Intended use: Kit components to be used during Intermittent Urinary Catheteriz Terminated |
KMJ | None listed |
| Jan 21, 2011 | H & P Industries, Inc. dba Triad Group Lubricating Jelly, Sterile, Non-staining, Made in the USA, packaged into the following size containers 5 gram tube, 2 ounce and 4 ounce tubes, 4 ounce bottle, 3 and 5 gram packets
Intended use: A pa Terminated |
KMJ | K871169 |
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