FDA.reportPublic FDA data

McKesson

Primary DI
00612479227323
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
137-5723
Device description
Skin Barrier Paste 2oz
Published
2019-03-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EZRCement, Stomal Appliance, Ostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZRCement, Stomal Appliance, OstomyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00612479227323PackageGS124In Commercial Distribution
00612479227316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479227323006124792273236124792273230612479227323
00612479227316006124792273166124792273160612479227316

GMDN Terms#

Term, Definition table
TermDefinition
Skin moisture barrier dressingA substance (e.g., cream, paste, ointment, gel, foam, or aerosol) intended to be applied to the skin/external mucosa (e.g., lips) to provide a protective moisture barrier to the external environment and/or to soften and sooth the skin. It is typically used for conditions such as dry, itchy, flaky, cracked, denuded, irritated or sun-damaged skin, cheilitis, and/or herpetic skin lesions. It may be intended for sensitive areas (e.g., areolar, perianal, lips, ears), dry skin and/or deep fissures (e.g., on the feet); it may include a disposable applicator. 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
false
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
06950715505984cofoeCofoe Medical Technology Co.,LtdEZR2025-02-18
06950715505649cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06950715505656cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06950715505663cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06950715505670cofoeCofoe Medical Technology Co.,LtdEZR2024-12-09
06948909454729BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-22
06948909454736BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-22
06948909454705BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-21
06948909454712BynexShaoxing Haoshide Medical Products Co., Ltd.EZR2024-08-21
00610075205479AdaptHOLLISTER INCORPORATEDEZR2022-12-01
00610075793013AdaptHOLLISTER INCORPORATEDEZR2022-12-01
00610075079100Karaya 5HOLLISTER INCORPORATEDEZR2022-12-01
00610075084166SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
10610075068057SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
20610075079104Karaya 5HOLLISTER INCORPORATEDEZR2022-12-01
10610075084163SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
20610075205473AdaptHOLLISTER INCORPORATEDEZR2022-12-01
10610075793010AdaptHOLLISTER INCORPORATEDEZR2022-12-01
20610075068054SecuriTHOLLISTER INCORPORATEDEZR2022-12-01
00612479227286McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-22
00612479227309McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-22
00612479227316McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-18
00612479227330McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-18
00612479227347McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2019-03-18
00612479227224McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09
00612479227248McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09
00612479227262McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09
00612479227231McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09
00612479227255McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09
00612479227279McKessonMCKESSON MEDICAL-SURGICAL INC.EZR2018-11-09