BioAccess Marrow Collection System

GUDID M791MH21500

BIOACCESS INC

Bone marrow collection/transfusion set

• Primary Device ID: M791MH21500
• NIH Device Record Key: 5717da18-1e28-41f1-b12d-2ea4e8814c63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioAccess Marrow Collection System
• Version Model Number: MH2150
• Company DUNS: 942203001
• Company Name: BIOACCESS INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M791MH21500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK970035

FDA Product Code

• LWE: Bone Marrow Collection/Transfusion Kit

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-11
• Device Publish Date: 2022-08-03

Devices Manufactured by BIOACCESS INC

• M791NGD10000 - Next Gen Driver: 2022-08-12
• M791NGD1005A0 - Next Gen Driver: 2022-08-12
• M791SBT10000 - Small Bone Tool: 2022-08-12
• M791SBT1000HT0 - Small Bone Tool: 2022-08-12
• M791SBT10010 - Small Bone Tool: 2022-08-12
• M791SBT1001A0 - Small Bone Tool: 2022-08-12
• M791SBT10040 - Small Bone Tool: 2022-08-12
• M791SBT10050 - Small Bone Tool: 2022-08-12