Airsep Corp. AS074-4

GUDID M638AS07440

Stationary oxygen concentrator

Primary Device ID	M638AS07440
NIH Device Record Key	a26d8742-770f-4d82-99f4-c78d951246f9
Commercial Distribution Status	In Commercial Distribution
Brand Name	Airsep Corp.
Version Model Number	Centrox
Catalog Number	AS074-4
Company DUNS	834499415
Company Name	AIRSEP CORPORATION
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	M638AS07440 [Primary]

CAW	Generator, Oxygen, Portable

Steralize Prior To Use	false
Device Is Sterile	false

M638AS07440 - Airsep Corp.	2025-03-10AirSep Centrox Oxygen Concentrator. 15 LPM Max continuous flow
M638AS07440 - Airsep Corp.	2025-03-10 AirSep Centrox Oxygen Concentrator. 15 LPM Max continuous flow
M638AS07710 - FreeStyle 5	2020-04-20 Portable Oxygen Concentrator, 1-5 LPM equivalent
M638AS0771CU0 - FreeStyle 5	2020-04-20 Portable Oxygen Concentrator, 1-5 LPM, Re-manufactured, complete unit.
M638AS0771U0 - FREESTYLE 5	2020-04-20 PORTABLE OXYGEN CONCENTRATOR, 1-5 LPM, PULSE DOSE, REMANUFACTURED
M638AS07810 - Focus	2020-04-20 Portable Oxygen Concentrator, 2 LPM equivalent
M638AS0781CU0 - Focus	2020-04-20 Portable Oxygen Concentrator, 2 LPM, Re-manufactured, complete unit
M638AS0781U0 - Focus	2020-04-20 Portable oxygen concentrator, 2 lpm pulse dose flow, remanufactured
M638AS09510 - FreeStyle	2020-04-20 Portable Oxygen Concentrator, 1 - 3 LPM Equivalent