FreeStyle 5

GUDID M766AS07710

FREESTYLE 5 OXYGEN CONCENTRATOR, 1-5 LPM

CAIRE INC.

Mobile/portable oxygen concentrator
Primary Device IDM766AS07710
NIH Device Record Keyfde24518-dda7-4634-84d6-d623a11d4a04
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle 5
Version Model NumberAS077-1
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
HIBCCM766AS07710 [Primary]

FDA Product Code

CAWGenerator, Oxygen, Portable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-04-20
Device Publish Date2016-01-01

On-Brand Devices [FreeStyle 5]

M766AS0771U0FREESTYLE 5 PORTABLE OXYGEN CONCENTRATOR, 1-5LPM, REFURBISHED
M766AS0771CU0FREESTYLE 5 PORTABLE OXYGEN CONCENTRATOR, 1-5LPM, REFURBISHED
M766AS07710FREESTYLE 5 OXYGEN CONCENTRATOR, 1-5 LPM

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