FDA.report

CVS Health

Primary DI
20050428279476
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
984301
Device description
Antibacterial Non-Stick Pads, all one size, 3 IN x 4 IN (7.6 cm x 10.1 cm). Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
Published
2020-03-02
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

Related Records

Contact Domains

Product Codes

CodeName
FRODressing, Wound, Drug

Product Code Classifications

CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20050428279476PackageGS172In Commercial Distribution
00050428279472PrimaryGS10
60050428279474Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2005042827947620050428279476
00050428279472000504282794720504282794720050428279472
6005042827947460050428279474

GMDN Terms

TermDefinition
Wound-nonadherent dressing, absorbent, antimicrobialA sterile wound covering typically in the form of a multi-layered pad having a material on its skin-contact surface that prevents adherence to the wound bed (e.g., soft silicone), thereby decreasing the potential for trauma to the wound and/or causing pain upon removal, and that contains an antimicrobial agent [e.g., silver (Ag), honey]. It is used to absorb blood and exudates from the wound, while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing with other wound-care products to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
18007467287xx@xx.xx

Regulatory Flags

DUNS number
062312574
Device count
8
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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