3B Medical, Inc.

GUDID 00853041003611

3B Medical's LARGE Elara full face mask, comes complete with mask frame, cushion and headgear

3B MEDICAL, INC.

CPAP/BPAP nasal mask, reusable

• Primary Device ID: 00853041003611
• NIH Device Record Key: 4d2d7b18-8ec2-465e-a2e1-62e5517a44ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3B Medical, Inc.
• Version Model Number: ELA1003
• 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: true
• 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	00853041003611 [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: 2016-09-07

On-Brand Devices [3B Medical, Inc.]

• 00853041003970: replacement headgear for 3B Medical's Elara fullface mask this headgear is one size
• 00853041003956: 3B Medical, Inc. Aerie replacement nasal cushion Large
• 00853041003949: 3B Medical's Aerie nasal mask replacement cushion Medium
• 00853041003932: 3B Medical, Inc.'s Aerie nasal mask replacement cushion size SMALL
• 00853041003925: 3B Medical, Inc.'s Aerie Nasal Mask size LARGE includes mask, size large cushion and headgear
• 00853041003901: 3B Medical's Aerie Nasal mask size MEDIUM includes mask, cushion size medium and headgear
• 00853041003895: 3B Medical's Aerie Nasal Mask size SMALL includes mask, size small cushion and headgear
• 00853041003864: 3B Medical , Inc. ECCO full face mask size medium for use with CPAP or bi-level systems includes
• 00853041003840: size small replacement cushion for the 3B ECCO fullface mask
• 00853041003833: medium replacement cushion for 3B ECCO fullface mask
• 00853041003826: large replacement cushion for 3B Medical's ECCO fullface mask
• 00853041003802: 3B Medical's Aerie Nasal Mask REPLACEMENT headgear ONE SIZE
• 00853041003796: Cirrus 6" humidifier extension tube
• 00853041003642: Large cushion replacement for 3B Medical's Elara full face mask
• 00853041003635: Medium replacement cushion for 3B Medical's Elara full face mask
• 00853041003628: small cushion replacement for 3B Medical's Elara fullface mask
• 00853041003611: 3B Medical's LARGE Elara full face mask, comes complete with mask frame, cushion and headgear
• 00853041003543: 3B Medical Rio's replacement headgear for the nasal pillow system
• 00853041003369: 3B Medical Inc.'s Replacement Frame + Nasal Pillow replacement for the Rio Nasal Pillow System
• 00853041003277: 3B Medical, Inc Rio Nasal Pillow mask Large includes a mask, headgear and a large nasal pillow c
• 00853041003260: 3B Medical, Inc Rio Nasal Pillow mask Medium includes a mask, headgear and a medium nasal pillow
• 00853041003253: 3B Medical, Inc Rio Nasal Pillow mask Small includes a mask, headgear and a small nasal pillow c
• 00853041003246: 3B Medical Inc.'s Replacement Frame + Nasal Pillow replacement for the Rio Nasal Pillow System
• 00853041003222: 3B Medical, Inc's Rio Nasal Pillow Mask All Size Kit includes the nasal mask, headgear and nasal
• 00853041003093: 3B Medical, Inc. Rio Nasal Pillow system replacement cushion size LARGE
• 00853041003086: 3B Medical, Inc. Rio Nasal Pillow system replacement cushion size MEDIUM
• 00853041003079: 3B Medical, Inc. Rio Nasal Pillow system replacement cushion size SMALL
• 00853041003048: replacement headgear for 3B Medical's ECCO full face mask, this headgear is not size specific