FDA.reportPublic FDA data

BioAccess Marrow Collection System

Primary DI
M791MH21500
Brand
BioAccess Marrow Collection System
Company
BIOACCESS INC
Model
MH2150
Published
2022-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9700350

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9700350

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M791MH21500PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
942203001
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M791NGD10000Next Gen DriverNGD10002022-08-04
M791NGD1005A0Next Gen DriverNGD1005A2022-08-04
M791SBT10000Small Bone ToolSBT10002022-08-04
M791SBT1000HT0Small Bone ToolSBT1000HT2022-08-04
M791SBT10010Small Bone ToolSBT10012022-08-04
M791SBT1001A0Small Bone ToolSBT1001A2022-08-04
M791SBT10040Small Bone ToolSBT10042022-08-04
M791SBT10050Small Bone ToolSBT10052022-08-04
M791SBT10050620Small Bone ToolSBT10050622022-08-04
M791SBT1005HTA0Small Bone ToolSBT1005HTA2022-08-04
M791WF1000Wire FixationWF1002022-08-04
M791TPK12080Traction Pin KitTPK12082019-12-10
M791TPK11040Traction Pin KitTPK11042018-09-20
M791TPK1200HT0Traction Pin KitTPK1200HT2018-09-20
M791TPK12010Traction Pin KitTPK12012018-09-20
M791TPK1201HT0Traction Pin KitTPK1201HT2018-09-20
M791TPK1203HT0Traction Pin KitTPK1203HT2018-09-20
M791TPK1207HTA0Traction Pin KitTPK1207HTA2018-09-20
M791TPK12090Traction Pin KitTPK12092018-09-20
M791TPK1213DTB0Traction Pin KitTPK1213DTB2018-09-20

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
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