FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
10195594365998
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA12BMGT3
Catalog number
SBA12BMGT3
Device description
BONE MARROW HARVEST PACK
Published
2021-10-07
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
LWEBone marrow collection/transfusion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWEBone Marrow Collection/Transfusion KitUnknown2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50195594365996PackageGS12In Commercial Distribution
10195594365998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559436599650195594365996
1019559436599810195594365998

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 Temperature15 Degrees Celsius30 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
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956397033CARDINAL HEALTHCardinal Health 200, LLCLWE2026-05-19
10198956138728CARDINAL HEALTHCardinal Health 200, LLCLWE2025-08-14
50198956138726CARDINAL HEALTHCardinal Health 200, LLCLWE2025-08-14
00810010894779Aero-MedAERO-MED, LLCLWE2025-03-06
50810010894774Aero-MedAero-Med, Ltd.LWE2025-03-06
10197106464427CARDINAL HEALTHCardinal Health 200, LLCLWE2023-10-18
50197106464425CARDINAL HEALTHCardinal Health 200, LLCLWE2023-10-18
10197106385647CARDINAL HEALTHCardinal Health 200, LLCLWE2023-08-21
50197106385645CARDINAL HEALTHCardinal Health 200, LLCLWE2023-08-21
10197106202715CARDINAL HEALTHCardinal Health 200, LLCLWE2023-04-03
50197106202713CARDINAL HEALTHCardinal Health 200, LLCLWE2023-04-03
04086000100380Bone Marrow Collection StandFresenius Kabi AGLWE2022-08-17
M791MH21500BioAccess Marrow Collection SystemBIOACCESS INCLWE2022-08-03
10195594757328CARDINAL HEALTHCardinal Health 200, LLCLWE2022-07-21
50195594757326CARDINAL HEALTHCardinal Health 200, LLCLWE2022-07-21
10195594569990CARDINAL HEALTHCardinal Health 200, LLCLWE2022-03-18
50195594569998CARDINAL HEALTHCardinal Health 200, LLCLWE2022-03-18
00880304640962Bilateral BMA KitBiomet Biologics, LLCLWE2021-10-30
50195594365996CARDINAL HEALTHCardinal Health 200, LLCLWE2021-10-07
10888439974607CARDINAL HEALTHCardinal Health 200, LLCLWE2021-04-22
50888439974605CARDINAL HEALTHCardinal Health 200, LLCLWE2021-04-22
10888439940060CARDINAL HEALTHCardinal Health 200, LLCLWE2021-01-15
50888439940068CARDINAL HEALTHCardinal Health 200, LLCLWE2021-01-15
10888439974737CARDINAL HEALTHCardinal Health 200, LLCLWE2021-01-04
50888439974735CARDINAL HEALTHCardinal Health 200, LLCLWE2021-01-04
10888439969085CARDINAL HEALTHCardinal Health 200, LLCLWE2020-12-21
50888439969083CARDINAL HEALTHCardinal Health 200, LLCLWE2020-12-21
10888439897265CARDINAL HEALTHCardinal Health 200, LLCLWE2020-10-13
50888439897263CARDINAL HEALTHCardinal Health 200, LLCLWE2020-10-13
10888439682564CARDINAL HEALTHCardinal Health 200, LLCLWE2020-09-11