3B Medical, Inc

GUDID 00853041003857

3B Medical , Inc. ECCO full face mask size Large for use with CPAP or bi-level systems includes mask, headgear and size Large cushion

3B MEDICAL, INC.

CPAP/BPAP nasal mask, reusable
Primary Device ID00853041003857
NIH Device Record Keydc58a5ae-d03d-43ef-84c2-33e2b1b025f0
Commercial Distribution StatusIn Commercial Distribution
Brand Name3B Medical, Inc
Version Model NumberEO1003
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
GS100853041003857 [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 Date2016-09-06

On-Brand Devices [3B Medical, Inc]

008530410038713B Medical , Inc. ECCO full face mask size small for use with CPAP or bi-level systems includes
008530410038573B Medical , Inc. ECCO full face mask size Large for use with CPAP or bi-level systems includes
008530410038193B Medical, Inc. filter replacements for cabinent and panel filters
008530410032393B Medical Inc.'s Replacement Frame + Nasal Pillow replacement for the Rio Nasal Pillow System

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