FDA.reportPublic FDA data

McKesson

Primary DI
00612479225053
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
16-8919
Device description
Lubricating Jelly STERILE | WATER SOLUBLE | GREASELESS | UNSCENTED 4 oz.
Published
2019-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMJLubricant, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479225046PackageGS112In Commercial Distribution
00612479225053PackageGS16In Commercial Distribution
00612479225039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479225046006124792250466124792250460612479225046
00612479225053006124792250536124792250530612479225053
00612479225039006124792250396124792250390612479225039

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical instrument lubricantA sterile substance intended to be applied to a sterile surgical instrument prior to use for device mechanical and patient lubrication purposes (e.g., to facilitate moving parts of device, and to facilitate movement between instrument and patient); it is not dedicated to a specific type of surgical instrument. It includes plant-derived materials (e.g., glycerin) and may also be intended for non-surgical applications (e.g., entry of a device into a body orifice). After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20612479282852McKessonM-1669H2026-05-26
20612479282883McKessonM-662G2026-05-26
20612479282890McKessonM-1667G2026-05-26
20612479282906McKessonM-1667H2026-05-26
20612479282913McKessonM-698G2026-05-26
20612479282920McKessonM-1666G2026-05-26
20612479282937McKessonM-1698G2026-05-26
20612479282944McKessonM-663G2026-05-26
20612479283019McKessonM-699G2026-05-26
20612479283194McKessonM-8699G2026-05-26
20612479283200McKessonM-8682G2026-05-26
20612479283217McKessonM-8698G2026-05-26
20612479283224McKessonM-8686G2026-05-26
20612479283231McKessonM-8697G2026-05-26
20612479283248McKessonM-8695G2026-05-26
20612479283255McKessonM-685G2026-05-26
20612479283385McKessonM-J494G2026-05-26
20612479283392McKessonM-J496G2026-05-26
20612479283408McKessonM-J493G2026-05-26
20612479283415McKessonM-J546G2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
40080196074199MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
17290100666156Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2025-04-02
00858276007557Sterile Bacteriostatic Lubricating GelMicro-tech UsaKMJ2025-03-05
10850025860489Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860079Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860222Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860284Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007441Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007472Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007502Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
E23905651Otoferm® CremeDreve Otoplastik GmbHKMJ2024-06-25
34026704921691ARROWTELEFLEX INCORPORATEDKMJ2024-04-08
30810132041762HCSConcordance Healthcare Solutions LLCKMJ2023-10-10
17290100663308Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
07290100663288Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
07290100663301Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2023-09-19
00304040165157Henry ScheinHENRY SCHEIN, INC.KMJ2023-07-31
00304040165164Henry ScheinHENRY SCHEIN, INC.KMJ2023-07-31
20326053104835Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
20326053104842Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
20326053104859Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-06-29
05030267124381OPTILUBE BOX OF 150 SACHETSIntersurgical IncorporatedKMJ2023-06-15
30810132040642HCSConcordance Healthcare Solutions LLCKMJ2023-04-07
00850047788115Oto Ease 12pk Display BoxWestone Laboratories, Inc.KMJ2023-03-02
00850047788122Oto-Ease 1/2oz bottle 1 packWestone Laboratories, Inc.KMJ2023-03-02
00850047788139Oto-Ease 1/2-oz bottles 5/pkWestone Laboratories, Inc.KMJ2023-03-02
00850047788146Oto-Ease Single Dose - 100/pkWestone Laboratories, Inc.KMJ2023-03-02
40080196291572MedlineMEDLINE INDUSTRIES, INC.KMJ2023-02-04
20326053118535Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.KMJ2023-01-13