FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10888439299243
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SERVALBGM3
Catalog number
SERVALBGM3
Device description
LARGE BURN PACK
Published
2018-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
50888439299241PackageGS11In Commercial Distribution
10888439299243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088843929924150888439299241
1088843929924310888439299243

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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 Temperature040 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047981Kendall923692362026-06-09
10192253047998Kendall923892382026-06-09
10192253048001Kendall923992392026-06-09
10192253048018Kendall924092402026-06-09
10192253048025Kendall924292422026-06-09
10192253048032Kendall924392432026-06-09
10192253046205Webcol511051102024-09-05
10192253047066Webcol68186818-2025-06-10
10192253047073Webcol6818-16818-12025-07-28
10884521008427Dover502750272016-09-24
10885380052538CARDINAL HEALTHC-CB2SC-CB2S2023-08-07
10885380052545CARDINAL HEALTHC-CB3SC-CB3S2023-08-07
10885380052569CARDINAL HEALTHC-CB6SC-CB6S2023-08-07
10885380052613CARDINAL HEALTHC-CB6C-CB62023-08-07
10885380107801CARDINAL HEALTHABP1201ABP12012016-07-22
10885380107818CARDINAL HEALTHASC1201ASC12012016-07-22
10885380107825CARDINAL HEALTHASC1210ASC12102016-07-22
10885380107832CARDINAL HEALTHASC1211ASC12112016-07-22
10885380107849CARDINAL HEALTHASC1220ASC12202016-07-22
10885380107856CARDINAL HEALTHASC1221ASC12212016-07-22

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