3B Medical, Inc

GUDID 00853041003239

3B Medical Inc.'s Replacement Frame + Nasal Pillow replacement for the Rio Nasal Pillow System size SMALL

3B MEDICAL, INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00853041003239
• NIH Device Record Key: e9150c41-a003-4611-a64b-d07b9d465ca8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3B Medical, Inc
• Version Model Number: RO5010
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853041003239 [Primary]

FDA Product Code

• BZD: Ventilator, Non-Continuous (Respirator)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• 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