FDA.report

CVS Health

Primary DI
20050428639294
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
211830
Device description
Flexible Fabric Antibacterial Bandages, assorted sizes, 12- Spot: 7/8 in (22 mm); 4- Knuckle: 1 1/2 in x 3 in ( 38 mm x 76 mm); 14- Strips: 1 in x 3 in (25 mm x 76 mm)
Published
2021-06-14
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
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20050428639294PackageGS172In Commercial Distribution
00050428639290PrimaryGS10
60050428639292Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2005042863929420050428639294
00050428639290000504286392900504286392900050428639290
6005042863929260050428639292

GMDN Terms

TermDefinition
Skin-cover adhesive strip, antimicrobialA small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
18007467287xx@xx.xx

Regulatory Flags

DUNS number
062312574
Device count
30
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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