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 ID00853041003611
NIH Device Record Key4d2d7b18-8ec2-465e-a2e1-62e5517a44ff
Commercial Distribution StatusIn Commercial Distribution
Brand Name3B Medical, Inc.
Version Model NumberELA1003
Company DUNS078517316
Company Name3B MEDICAL, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100853041003611 [Primary]

FDA Product Code

BZDVentilator, Non-Continuous (Respirator)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-07

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

00853041003970replacement headgear for 3B Medical's Elara fullface mask this headgear is one size
008530410039563B Medical, Inc. Aerie replacement nasal cushion Large
008530410039493B Medical's Aerie nasal mask replacement cushion Medium
008530410039323B Medical, Inc.'s Aerie nasal mask replacement cushion size SMALL
008530410039253B Medical, Inc.'s Aerie Nasal Mask size LARGE includes mask, size large cushion and headgear
008530410039013B Medical's Aerie Nasal mask size MEDIUM includes mask, cushion size medium and headgear
008530410038953B Medical's Aerie Nasal Mask size SMALL includes mask, size small cushion and headgear
008530410038643B Medical , Inc. ECCO full face mask size medium for use with CPAP or bi-level systems includes
00853041003840size small replacement cushion for the 3B ECCO fullface mask
00853041003833medium replacement cushion for 3B ECCO fullface mask
00853041003826large replacement cushion for 3B Medical's ECCO fullface mask
008530410038023B Medical's Aerie Nasal Mask REPLACEMENT headgear ONE SIZE
00853041003796Cirrus 6" humidifier extension tube
00853041003642Large cushion replacement for 3B Medical's Elara full face mask
00853041003635Medium replacement cushion for 3B Medical's Elara full face mask
00853041003628small cushion replacement for 3B Medical's Elara fullface mask
008530410036113B Medical's LARGE Elara full face mask, comes complete with mask frame, cushion and headgear
008530410035433B Medical Rio's replacement headgear for the nasal pillow system
008530410033693B Medical Inc.'s Replacement Frame + Nasal Pillow replacement for the Rio Nasal Pillow System
008530410032773B Medical, Inc Rio Nasal Pillow mask Large includes a mask, headgear and a large nasal pillow c
008530410032603B Medical, Inc Rio Nasal Pillow mask Medium includes a mask, headgear and a medium nasal pillow
008530410032533B Medical, Inc Rio Nasal Pillow mask Small includes a mask, headgear and a small nasal pillow c
008530410032463B Medical Inc.'s Replacement Frame + Nasal Pillow replacement for the Rio Nasal Pillow System
008530410032223B Medical, Inc's Rio Nasal Pillow Mask All Size Kit includes the nasal mask, headgear and nasal
008530410030933B Medical, Inc. Rio Nasal Pillow system replacement cushion size LARGE
008530410030863B Medical, Inc. Rio Nasal Pillow system replacement cushion size MEDIUM
008530410030793B Medical, Inc. Rio Nasal Pillow system replacement cushion size SMALL
00853041003048replacement headgear for 3B Medical's ECCO full face mask, this headgear is not size specific

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