FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
50195594757326
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
SBA30BMMDA
Catalog number
SBA30BMMDA
Device description
CE BONE MARROW KIT
Published
2022-07-21
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
50195594757326PackageGS12In Commercial Distribution
10195594757328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019559475732650195594757326
1019559475732810195594757328

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.

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
50198956138726CARDINAL HEALTHCardinal Health 200, LLCLWE2025-08-14
50810010894774Aero-MedAero-Med, Ltd.LWE2025-03-06
50197106464425CARDINAL HEALTHCardinal Health 200, LLCLWE2023-10-18
50197106385645CARDINAL HEALTHCardinal Health 200, LLCLWE2023-08-21
50197106202713CARDINAL HEALTHCardinal Health 200, LLCLWE2023-04-03
04086000100380Bone Marrow Collection StandFresenius Kabi AGLWE2022-08-17
M791MH21500BioAccess Marrow Collection SystemBIOACCESS INCLWE2022-08-03
50195594569998CARDINAL HEALTHCardinal Health 200, LLCLWE2022-03-18
00880304640962Bilateral BMA KitBiomet Biologics, LLCLWE2021-10-30
50195594365996CARDINAL HEALTHCardinal Health 200, LLCLWE2021-10-07
50888439974605CARDINAL HEALTHCardinal Health 200, LLCLWE2021-04-22
50888439940068CARDINAL HEALTHCardinal Health 200, LLCLWE2021-01-15
50888439974735CARDINAL HEALTHCardinal Health 200, LLCLWE2021-01-04
50888439969083CARDINAL HEALTHCardinal Health 200, LLCLWE2020-12-21
50888439897263CARDINAL HEALTHCardinal Health 200, LLCLWE2020-10-13
50888439682562CARDINAL HEALTHCardinal Health 200, LLCLWE2020-09-11
50888439804049CARDINAL HEALTHCardinal Health 200, LLCLWE2020-06-10
50888439802977CARDINAL HEALTHCardinal Health 200, LLCLWE2020-05-07
50888439801918CARDINAL HEALTHCardinal Health 200, LLCLWE2020-04-07
50888439627495CARDINAL HEALTHCardinal Health 200, LLCLWE2020-03-06
50888439257630CARDINAL HEALTHCardinal Health 200, LLCLWE2019-09-09
50888439024515CARDINAL HEALTHCardinal Health 200, LLCLWE2019-05-31
20809160236274Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.LWE2019-04-19
50888439403518CARDINAL HEALTHCardinal Health 200, LLCLWE2019-03-29
00880304451759BMA KitBiomet Biologics, LLCLWE2019-02-22
50888439338889CARDINAL HEALTHCardinal Health 200, LLCLWE2019-02-19
50888439367315CARDINAL HEALTHCardinal Health 200, LLCLWE2019-02-04
50810010890455Aero-MedAero-Med, Ltd.LWE2019-01-16
50888439017999CARDINAL HEALTHCardinal Health 200, LLCLWE2018-06-13
50887488971061CARDINAL HEALTHCardinal Health 200, LLCLWE2018-04-26