FreeStyle 5

GUDID M638AS0771CU0

Portable Oxygen Concentrator, 1-5 LPM, Re-manufactured, complete unit.

AIRSEP CORPORATION

Mobile/portable oxygen concentrator
Primary Device IDM638AS0771CU0
NIH Device Record Keyaee65a8f-84ae-4107-b2b4-4dd707145ca7
Commercial Distribution StatusIn Commercial Distribution
Brand NameFreeStyle 5
Version Model NumberAS077-1CU
Company DUNS834499415
Company NameAIRSEP CORPORATION
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
HIBCCM638AS0771CU0 [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 Date2015-06-15

On-Brand Devices [FreeStyle 5]

M638AS0771U0PORTABLE OXYGEN CONCENTRATOR, 1-5 LPM, PULSE DOSE, REMANUFACTURED
M638AS0771CU0Portable Oxygen Concentrator, 1-5 LPM, Re-manufactured, complete unit.
M638AS07710Portable Oxygen Concentrator, 1-5 LPM equivalent

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