3B Medical, Inc

GUDID 00853041003819

3B Medical, Inc. filter replacements for cabinent and panel filters

3B MEDICAL, INC.

Stationary oxygen concentrator

• Primary Device ID: 00853041003819
• NIH Device Record Key: 72798eea-d7b9-4307-aef6-6fdf959c6bd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3B Medical, Inc
• Version Model Number: CIR1020 CIR1030
• Company DUNS: 078517316
• Company Name: 3B MEDICAL, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853041003819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131968

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-18

On-Brand Devices [3B Medical, Inc]

• 00853041003871: 3B Medical , Inc. ECCO full face mask size small for use with CPAP or bi-level systems includes
• 00853041003857: 3B Medical , Inc. ECCO full face mask size Large for use with CPAP or bi-level systems includes
• 00853041003819: 3B Medical, Inc. filter replacements for cabinent and panel filters
• 00853041003239: 3B Medical Inc.'s Replacement Frame + Nasal Pillow replacement for the Rio Nasal Pillow System