FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50197106471072
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SER11BR07K
Catalog number
SER11BR07K
Device description
BURN PACK
Published
2023-12-11
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
50197106471072PackageGS11In Commercial Distribution
10197106471074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019710647107250197106471072
1019710647107410197106471074

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. 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
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

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