HELiOS 46

GUDID M766B702099000

Base Liquid Oxygen Respiratory Equipment, Top Fill, 10 LPM, 20 PSI

CAIRE INC.

Stationary liquid oxygen container
Primary Device IDM766B702099000
NIH Device Record Key9f4a0f9b-44c4-43d6-9968-3e60e5ba5554
Commercial Distribution StatusIn Commercial Distribution
Brand NameHELiOS 46
Version Model NumberB-702099-00
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
HIBCCM766B702099000 [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 Date2016-08-17

On-Brand Devices [HELiOS 46]

M766B702099000Base Liquid Oxygen Respiratory Equipment, Top Fill, 10 LPM, 20 PSI
M766B701652000Base Liquid Oxygen Respiratory Equipment, Top Fill, 10 LPM, 20 PSI

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