FDA.reportPublic FDA data

Aero-Med

Primary DI
00810010894779
Brand
Aero-Med
Company
AERO-MED, LLC
Model
AMM19300
Catalog number
AMM19300
Device description
BONE MARROW COLLECTION KIT
Published
2025-03-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
50810010894774PackageGS110In Commercial Distribution
00810010894779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081001089477450810010894774
00810010894779008100108947798100108947790810010894779

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow collection/transfusion setA sterile collection of instruments, pharmaceuticals, and other items intended for use in combination to collect and/or deliver bone marrow. This is a single-use device.

Regulatory Flags#

DUNS number
194550042
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213908Aero-MedCA52100ACA52100A2026-09-25
10885380213922Aero-MedCA65350CA653502026-09-25
00810010894687Aero-MedAMM18150AMM181502026-09-24
10885380122057CARDINAL HEALTHCA1475CA14752019-04-12
10885380184376Aero-MedCA3100ACA3100A2021-02-24
10885380187902Aero-MedCA38275CA382752026-02-20
10885380189159Aero-MedCA36975CA369752026-02-20
10885380194733Aero-MedCA48325CA483252023-02-24
10885380195365Aero-MedCA49825CA498252023-04-20
10885380202605Aero-MedCA42225ACA42225A2024-05-10
10885380205217Aero-MedCA54650ACA54650A2024-08-28
10885380208515Aero-MedCA6000BCA6000B2025-06-19
10885380211195Aero-MedCA19925ACA19925A2026-02-13
10885380211218Aero-MedCA7225ACA7225A2026-03-20
10885380175237Aero-MedCA23450CA234502019-10-07
10885380199165Aero-MedCA52075CA520752024-01-31
10885380210891Aero-MedCA62250CA622502026-06-10
10885380213465Aero-MedCA64850CA648502026-06-10
10192253062595Aero-MedCA28600ACA28600A2022-08-26
10192253062601Aero-MedCA37125CA371252022-08-26

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
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
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