FDA.report

COLOPLAST PREP

Primary DI
00311701007930
Brand
COLOPLAST PREP
Company
Coloplast A/S
Model
0925
Catalog number
0925
Device description
Skin Barrier Wipe
Published
2022-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NECBandage, liquid, skin protectant

Product Code Classifications

CodeDeviceSpecialtyClass
NECBandage, Liquid, Skin ProtectantGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00311701007930PackageGS11In Commercial Distribution
00311701007039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00311701007930003117010079303117010079300311701007930
00311701007039003117010070393117010070390311701007039

GMDN Terms

TermDefinition
Synthetic-polymer liquid barrier dressing, non-sterileA non-sterile liquid preparation composed of synthetic polymer materials intended to form a thin protective film when applied to superficial wounds (e.g., minor cuts, abrasions) and/or intact skin (typically sensitive areas such as around a stoma), to reduce exposure to external contaminants; may also be intended to augment the adherence of medical adhesives, or provide a protective interface when removing medical adhesives. It may be presented as a wipe, swab, or spray. After application, this device cannot be reused.

Device Sizes

TypeValueUnit
Total Volume2Fluid Ounce

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)533-0464healthcarecs@coloplast.com

Regulatory Flags

DUNS number
305524696
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
false
Sterilization required before use
false

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03600040963876ColoplastAC5904AC59042026-01-30
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03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

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