FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50198956142297
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SER11BULVD
Catalog number
SER11BULVD
Device description
MINOR BURN PACK
Published
2025-08-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
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
50198956142297PackageGS12In Commercial Distribution
10198956142299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019895614229750198956142297
1019895614229910198956142299

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
961027315
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
true
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
10192253004205Monoject1525SA1525SA2026-07-13
10192253004410Monoject8507MW8507MW2026-07-13
10192253004540Monoject8533SA8533SA2026-07-13
10192253004588Monoject8537MW8537MW2026-07-13
10192253004625SharpSafety8540SA8540SA2026-07-13
10192253004885Monoject8900MW8900MW2026-07-13
10192253005127Monoject8979MW8979MW2026-07-13
10192253005509Monoject8525Y8525Y2026-07-13
10192253071894Argyle47802478022026-07-13
20192253017455Kendall31469219314692192021-05-05
20192253017547Medi-Trace Cadence22550A22550A-2021-07-28
20192253017554Medi-Trace Cadence22550P22550P-2021-08-19
20192253017578Medi-Trace Cadence22550PC22550PC2021-07-29
20192253017585Medi-Trace Cadence22550R22550R-2021-07-29
20192253017608Medi-Trace Cadence22660R22660R-2024-02-28
20192253017622Medi-Trace Cadence22770P22770P2021-08-19
20192253017639Medi-Trace Cadence22770PC22770PC2021-07-29
20192253017721Kendall31319281313192812021-05-05
20192253018889Medi-Trace Cadence22770R22770R-2021-07-29
20192253017592Medi-Trace Cadence22660PC22660PC2021-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956483804CARDINAL HEALTHCardinal Health 200, LLCOJJ2026-06-01
10194717121831Regard™ROI CPS, LLCOJJ2025-01-28
10195327596453Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327627782Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327627836Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327632724Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327651381Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327655921Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-07-29
10195327672584Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-04-28
10195327623074Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2024-02-11
10194717118619Regard™ROI CPS, LLCOJJ2024-02-07
10195327578848Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-24
10195327494445Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-21
10195327494513Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-21
10195327548353Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-12-21
10195327523282Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-10-15
10195327523763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-10-15
10195327513375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-10-01
10195327471576Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-08-13
10195327443856Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-07-29
10195327376161Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-06-13
10195327409968Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-05-21
10195327328047Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-29
10195327328337Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-22
10195327328375Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-22
10195327320928Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-15
10195327325725Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OJJ2023-01-15
10197106102732CARDINAL HEALTHCardinal Health 200, LLCOJJ2023-01-13
10195594600457CARDINAL HEALTHCardinal Health 200, LLCOJJ2023-01-09
10197106099360CARDINAL HEALTHCardinal Health 200, LLCOJJ2023-01-04