MedtechSourcebook

Airgas Therapeutics LLC

Contract manufacturer · Plumsteadville, PA

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

FDA registration
2518435 (openFDA record; or search FDA's registration database)
FEI number
2518435
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
Airgas Therapeutics LLC (FDA owner/operator no. 10084091)
Registered address
6141 Easton Road, P/O. Box 310, Plumsteadville, PA 18949
Contract listings
7 device listings, 8 product codes, first listed Jan 17, 2022
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
BXKGas, Calibration (Specified Concentration)Class IAnesthesiologyContract manufacturingJan 17, 2022
DSPSystem, Balloon, Intra-Aortic And ControlClass IICardiovascularContract manufacturingJan 17, 2022
KZJDevice, Gas GeneratingClass IMicrobiologyContract manufacturingJan 17, 2022
NXFGas, Laser GeneratingClass IGeneral and plastic surgeryContract manufacturingJan 17, 2022
PHONormothermic Preservation System For Transplantation Of Initially Unacceptable Donor LungsClass IIIGastroenterology and urologyContract manufacturingMar 28, 2024
QBANormothermic Machine Perfusion System For The Preservation Of Standard Criteria Donor Lungs Prior To TransplantationClass IIIGastroenterology and urologyContract manufacturingMar 28, 2024
QIKOrgan Care System (Ocs) Heart SystemClass IIICardiovascularContract manufacturingMar 28, 2024
QQKNormothermic Machine Perfusion System For The Preservation Of Donor Livers Prior To TransplantationClass IIIGastroenterology and urologyContract manufacturingMar 28, 2024