FDA.report

CVS Health

Primary DI
20050428611641
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
380404
Device description
Waterproof Adhesive Tape, 2 roll, 1/2 IN x 5 YD (1.27 cm x 4.5 m)
Published
2020-01-30
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
KGXTape And Bandage, Adhesive

Product Code Classifications

CodeDeviceSpecialtyClass
KGXTape And Bandage, AdhesiveGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20050428611641PackageGS172In Commercial Distribution
00050428611647PrimaryGS10
60050428611649Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2005042861164120050428611641
00050428611647000504286116470504286116470050428611647
6005042861164960050428611649

GMDN Terms

TermDefinition
Waterproof skin adhesive tapeA long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
18007467287xx@xx.xx

Regulatory Flags

DUNS number
062312574
Device count
2
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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