FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50885380052222
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
C-WMD18P
Catalog number
C-WMD18P
Device description
MEDICATED PETROLATUM GAUZE 1X8 STER
Published
2019-05-29
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
GERGAUZE, EXTERNAL (WITH DRUG/BIOLOGIC/ANIMAL SOURCE MATERIAL)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GERGAUZE, EXTERNAL (WITH DRUG/BIOLOGIC/ANIMAL SOURCE MATERIAL)

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K921289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K921289000INMAN MEDICAL PETROLATUM DRESSINGInman Medical Corp.1992-11-10FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20885380052221PackageGS150In Commercial Distribution
50885380052222PackageGS14In Commercial Distribution
10885380052224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088538005222120885380052221
5088538005222250885380052222
1088538005222410885380052224

GMDN Terms#

Term, Definition table
TermDefinition
Petrolatum woven gauze pad, sterileA sterile, non-medicated device in the form of a patch or swab (also referred to as a sponge) made from woven material (e.g., cotton, cellulose) and primarily designed to absorb fluids for medical purposes; it is impregnated with petrolatum to increase its nonadherent properties. The device is typically used to clean, cover, or pack wounds, abrasions or burns and absorb their exudates, or to absorb body-surface exudates; it is not however a dedicated burn dressing. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20612479198559McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
10612479198514McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
40612479198539McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
40612479198560McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-06-09
10612479198576McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
10612479198606McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
40612479198591McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
40612479198621McKessonMCKESSON MEDICAL-SURGICAL INC.GER2020-05-18
00888499000929CARDINAL HEALTHCardinal Health 200, LLCGER2019-10-14
00888499000936CARDINAL HEALTHCardinal Health 200, LLCGER2019-10-14
10885380052224CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052231CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052248CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052262CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052279CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052286CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052293CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052309CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052316CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052323CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
10885380052330CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052239CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
20885380052245CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052260CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
20885380052276CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052284CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052291CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052307CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052314CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29
50885380052321CARDINAL HEALTHCardinal Health 200, LLCGER2019-05-29