AirSep FreeStyle 5

GUDID M766AS077101CU0

AirSep FreeStyle 5 Portable Oxygen Concentrator, 1-5LPM, External Battery, Re-Manufactured

CAIRE INC.

Mobile/portable oxygen concentrator
Primary Device IDM766AS077101CU0
NIH Device Record Keyc6736135-abed-4330-a036-fe8a5e1fb730
Commercial Distribution StatusIn Commercial Distribution
Brand NameAirSep FreeStyle 5
Version Model NumberAS077-101CU
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
HIBCCM766AS077101CU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

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 Number2
Public Version Date2020-04-20
Device Publish Date2018-09-11

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