FDA.report

McKesson

Primary DI
00612479193239
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
1718
Device description
Dermal Wound Cleanser, 4 oz
Published
2019-03-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479193239PackageGS112In Commercial Distribution
00612479193222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479193239006124791932396124791932390612479193239
00612479193222006124791932226124791932220612479193222

GMDN Terms

TermDefinition
Secretion/excreta skin cleanserA non-sterile substance typically used by ostomists or incontinent persons to gently cleanse skin exposed to intestinal secretions (e.g., around a stoma or fistula) or to excreta (urine or faeces). It is typically used to replace cleaning with soap and water which can aggravate the skin causing soreness/inflammation; it may also be used to remove small amounts of adhesive residue or barrier creams. The device is provided in a variety of forms including a solution, sachets, or disposable wipes. After application, this device cannot be reused.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
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
true
Sterilization required before use
false

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00612479135468McKesson16-71352026-03-11
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00612479185388McKesson70-1121MCK2026-03-11
00612479185395McKesson70-1122MCK2026-03-11
40612479280920McKesson16-1000-PMBL2026-02-26
40612479262162McKesson18-3300M2026-02-23
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10612479281582McKesson181-342252026-02-06
00612479278356McKesson16-61442026-01-26
00612479278370McKesson16-61482026-01-26
00612479278387McKesson16-61682026-01-26
00612479278431McKesson16-618102026-01-26

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