FDA.reportPublic FDA data

CVS Health

Primary DI
20050428593114
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
245031
Device description
Hydrocolloid Gel Adhesive Pads, 3.94 IN x 3.94 IN (100 mm x 100 mm)
Published
2020-09-07
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
NADDressing, Wound, Occlusive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NADDressing, Wound, OcclusiveGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20050428593114PackageGS124In Commercial Distribution
00050428593110PrimaryGS10
60050428593112Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2005042859311420050428593114
00050428593110000504285931100504285931100050428593110
6005042859311260050428593112

GMDN Terms#

Term, Definition table
TermDefinition
Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobialA wound covering, typically made of a hydrocolloid, hydrofibre, or alginate (salts and acids extracted from seaweed), intended to produce a water-absorbent gel upon contact with wound exudate; it does not contain an antimicrobial agent. The device assists in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) for minimal wound maceration, allowing wound debridement, and creating a moist wound-healing environment. The device may be in the form of a flat sheet/film, ribbon, rope, foam, liquid, paste, or powder. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18007467287xx@xx.xx

Regulatory Flags#

DUNS number
062312574
Device count
3
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428269381CVS Health9965529965522016-09-21
00050428339770CVS Health16CVS01507NEW3291982026-03-20
00050428143216CVS0504281432162026-08-18
00050428124505CVS Health8448202026-08-14
00050428034873CVS Health5518372026-08-08
00050428034880CVS Health5518362026-08-08
00050428167335CVSMD300CN330R2026-07-10
00050428167342CVSMD300C2052026-07-10
00050428426777CVS HealthCVS991268RR2026-06-24
00050428005873CVS695540BC332025-11-19
00050428280669CVS HealthCVS5248V12026-06-04
00050428359112CVS HealthCVS739091V12026-06-04
00050428453599CVS HealthCVS9107552026-06-04
10050428265106CVS Glucose Meter8000-107532021-03-22
00050428050460CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428082102CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087268CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087589CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428049556CVS Health6 Days Sooner Pregnancy TestN/A2026-06-02
00050428142516CVS0504281425162026-05-28

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04719873697816NACARILEX MEDICAL, INC.NAD2026-08-26
04719873697823NACARILEX MEDICAL, INC.NAD2026-08-26
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05060483573083Russell Chest Seal - Twin (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-24
05060483570006Russell Chest Seal (US Version)SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDNAD2026-07-20
00850088144642CARBOUNingbo kehu Medical Technology Co.,Ltd.NAD2026-07-10
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00850087488686CeeportCEEPORT INC.NAD2026-06-30
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06970206827067Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827074Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827081Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22
06970206827098Ourmed Foam DressingJiangsu NewValue Medical Products Co.,Ltd.NAD2026-06-22