Companion 1000

GUDID M766B775532000

Portable Liquid Oxygen Respirator Equipment, Top Fill, 15 LPM, 20 PSI

CAIRE INC.

Portable liquid oxygen unit
Primary Device IDM766B775532000
NIH Device Record Keyac0fa496-10f9-42f1-bd02-90659a9f8eea
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompanion 1000
Version Model NumberB-775532-00
Company DUNS807537683
Company NameCAIRE 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 Batchfalse
Serial Numbertrue
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
HIBCCM766B775532000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BYJUnit, Liquid-Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-10-23
Device Publish Date2016-08-24

On-Brand Devices [Companion 1000]

M766B775532000Portable Liquid Oxygen Respirator Equipment, Top Fill, 15 LPM, 20 PSI
M766B775099000Portable Liquid Oxygen Respirator Equipment, Top Fill, 6 LPM, 20 PSI

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