Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2518435

FEI Number

2518435

Entity Name

Airgas Therapeutics LLC

City/State/Country

PLUMSTEADVILLE, PA, US

Establishment Address

6141 Easton Road, P/O. Box 310, PLUMSTEADVILLE, PA 18949, US

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Airgas Therapeutics LLC (Owner Number: 10084091)

Owner / Operator Contact Address

6141 Easton Road, P.O. Box 310, Plumsteadville, PA 18949, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Organ Care System (OCS) Heart Laser Gas Mixture Ulspira TS ULSPIRA TS Aerobic Anaerobic Gas Mixture Calibration Mixture Slope Gas Aerobic/Anaerobic Gas Mixture Lung Diffusion Mixture Blood gas Mixture

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPO	Gases Used Within Eye To Place Pressure On Detached Retina	Ophthalmic	Class 3	886.4270	2022-01-17
QIK	Organ Care System (Ocs) Heart System	Unknown	Class 3	N/A	2024-03-28
NXF	Gas, Laser Generating	General, Plastic Surgery	Class 1	878.4810	2022-01-17
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2023-08-07
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2023-08-07
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2023-08-07
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2023-08-07
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2023-08-07
MRP	Analyzer, Nitric Oxide	Anesthesiology	Class 2	868.2380	2025-01-20
MRN	Apparatus, Nitric Oxide Delivery	Anesthesiology	Class 2	868.5165	2025-01-20
MRQ	Analyzer, Nitrogen Dioxide	Anesthesiology	Class 2	868.2385	2025-01-20
MRO	Apparatus, Nitric Oxide, Backup Delivery	Anesthesiology	Class 2	868.5165	2025-01-20
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2025-01-20
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2022-01-17
KZJ	Device, Gas Generating	Microbiology	Class 1	866.2580	2022-01-17
LPO	Gases Used Within Eye To Place Pressure On Detached Retina	Ophthalmic	Class 3	886.4270	2022-01-17
BXK	Gas, Calibration (Specified Concentration)	Anesthesiology	Class 1	868.6400	2022-01-17

Official Correspondent

Timothy Warren

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Airgas Therapeutics LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072469	Digiflo, Inc.	DIGIFLO CONCENTRATOR ANALYZER	2008-01-03
K903893	Datascope Corp.	DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL	1990-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I
Z-0029-2026	NOXBOX LTD	2	NOxBOXi Nitric Oxide Delivery System; Model Numbers: NOXBOX-I

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1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US
2350043	RED BALL OXYGEN COMPANY	Shreveport, LA, US
1625735	MATHESON TRI-GAS, INC.	HOUSTON, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518435. Last updated year: 2026. Please use registration number 2518435 when referencing this establishment in official correspondence.