BioAccess Marrow Collection System

GUDID M791MH21500

BIOACCESS INC

Bone marrow collection/transfusion set
Primary Device IDM791MH21500
NIH Device Record Key5717da18-1e28-41f1-b12d-2ea4e8814c63
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioAccess Marrow Collection System
Version Model NumberMH2150
Company DUNS942203001
Company NameBIOACCESS INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM791MH21500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWEBone Marrow Collection/Transfusion Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-11
Device Publish Date2022-08-03

Devices Manufactured by BIOACCESS INC

M791NGD10000 - Next Gen Driver2022-08-12
M791NGD1005A0 - Next Gen Driver2022-08-12
M791SBT10000 - Small Bone Tool2022-08-12
M791SBT1000HT0 - Small Bone Tool2022-08-12
M791SBT10010 - Small Bone Tool2022-08-12
M791SBT1001A0 - Small Bone Tool2022-08-12
M791SBT10040 - Small Bone Tool2022-08-12
M791SBT10050 - Small Bone Tool2022-08-12

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