FDA.report

AIRSEP CORP.

Matched from indexed company URL: AIRS, Inc.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
13190443006277965AIRSEP CORP.1N2026-01-01260 Creekside Dr Buffalo NY US 14228
22498013003238169AirScan, Inc.1N2026-01-0167 Beaver Ave Annandale NJ US 08801
30061041913006104191AirStrip Technologies, Inc.1N2026-01-012915 W Bitters Rd. Suite 215 SAN ANTONIO TX US 78248
30248201863024820186AIRS Medical Inc.1N2026-01-0113-14F, Keungil Tower 223, Teheran-ro, Gangnam-gu Seoul KR 06142

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
M638AS07440Airsep Corp. - AirSep Centrox Oxygen Concentrator. 15 LPM Max continuous flow716-691-0202info@airsep.com

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
192971514339982K991876SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATEJPK1999-06-17
192971440523780K884623SAFE-TEC CAPILLARY BLOOD COLLECTION TUBEGIO1988-12-01
3105001397472526K253775SwiftMRQIH2026-03-26
3105001889734827K251483SwiftSight-BrainQIH2025-09-23
3105001437956810K230854SwiftMRLLZ2023-10-27
638791616534223K221203AHI SystemQNV2022-07-14
3105001422796129K220416SwiftMRLLZ2022-05-25
638791065300707K212219AHI SystemQNV2021-12-03
638791043142467K211949
3105001975243946K210999SwiftMRLLZ2021-10-14
638791992348465K160862AirStrip RPMMSX2016-09-19
638791901877138K142106DECISIO HEALTH PATIENT DASHBOARDMWI2015-01-18
638791734020733K133450AIRSTRIP REMOTE PATIENT MONITORINGMWI2014-02-14
638791886953055K112235AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWINGMWI2011-08-26
310311640404332K101154CENTROX, RELIANT, ULTROX, AS-D+, AS-E, AS-G, AS-J, AS-K AND AS-LCAW2011-03-28
638791645273910K090269AIRSTRIP OBHGM2009-02-13
638791995983979DEN200022Analytic for Hemodynamic Instability (AHI)QNV2021-03-01
192971653923470
310311783091289

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
LLZ32023-10-27
QNV32022-07-14
MWI32015-01-18
QIH22026-03-26
JPK21999-06-17
GIO21988-12-01
MSX12016-09-19
CAW12011-03-28
HGM12009-02-13

NDC

PMN

SwiftMR

2023-10-27

Airs Medical, Inc.

GUDID

Airsonett AIR-4 - Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.

Airsonett AB

2023-02-01