FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594365996
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
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
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/plastic surgical procedure kit, non-medicated, single-useA collection of various surgical instruments, sometimes with dressings and/or other materials, intended to be used to: 1) assist a range of surgical procedures across multiple clinical specialities typically as a general-purpose tray; or 2) assist with a plastic surgery procedure. It does not contain pharmaceuticals. 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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

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
10195594365998CARDINAL 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