FDA.reportPublic FDA data

CVS Health

Primary DI
20050428616806
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
310381
Device description
3-Step Kit for Minor Burns, 6 pieces: gauze pads, hydrogel burn pads, rolled gauze.
Published
2019-12-30
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

Product Codes#

Code, Name table
CodeName
OJJBurn Kit Without Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJJBurn Kit Without DrugGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20050428616806PackageGS118In Commercial Distribution
00050428616802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2005042861680620050428616806
00050428616802000504286168020504286168020050428616802

GMDN Terms#

Term, Definition table
TermDefinition
Burn kit, non-medicatedA collection of devices designed to treat first or second degree burns typically as first aid therapy by emergency medical services (EMS); it does not include pharmaceuticals. It typically includes burn dressings, burn gels, gauze, cold packs, adhesive tapes, and gloves; it may include additional devices such as scissors and masks. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062312574
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
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
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
20050428020849CVS HealthCVS376561V22026-03-23
00050428339770CVS Health16CVS015073291982026-03-20
10050428001025CVS 797412BM22-12026-02-27
00050428005408CVS 841855WF032026-02-13
00050428005415CVS 845712WF132026-02-13
00050428005422CVS 837160WF232026-02-13
40050428029495CVS6354782026-02-13
00050428057186CVSHealth1017042026-02-04
00050428073421CVSHealth1044172026-02-04
00050428080863CVSHealth1059932026-02-04
00050428005583CVS 689466LB152026-01-28
10050428005603CVS 689509LB262026-01-26
10050428005610CVS 689573LB462026-01-23
10050428273484CVS Health TamponsBCVGC32(L/R)2025-12-31
00050428005842CVS 695535BM332025-12-11
00050428005804CVS 275172BF7222025-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50198956430189CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-24
00766588260051Burn Dressing Small - Red Velcro BagCertified Safety Manufacturing, Inc.OJJ2026-03-23
50198956399035CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-19
50198956413670CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-16
50198956413199CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-03-10
50198956328257CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-02-13
50198956360769CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-02-09
M689SBK1200000030BurnFree Burn Kit 10/CaseSafeguard US Operating, LLCOJJ2026-02-05
50198956306262CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-02-02
50198956270235CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-01-13
50198956307207CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-01-05
50198956254853CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-12-10
50198956251296CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-12-02
50198956217834CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-28
50198956267310CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-28
50198956264166CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-25
50198956218237CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-13
50198956256567CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-13
50198956258523CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-13
50198956259599CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-11-11
50198956194128CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-09-18
50198956183436CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-09-03
50198956142297CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-08-28
50198956092028CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-08-08
50198956153514CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-08-05
M689FSKHA00020First Responder Food Service Burn Kit 5/CaseSafeguard US Operating, LLCOJJ2025-07-30
40198459418632MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.OJJ2025-07-21
50198956137811CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-07-03
50197106928712CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-06-30
50198956119756CARDINAL HEALTHCardinal Health 200, LLCOJJ2025-06-23