← Back to catalogue

Ulspira TS

FDA UDI

Class II (US FDA UDI)

by Airgas Therapeutics

Identity

Trade Name
Ulspira TS FDA UDI
Generic Name
Nitric oxide delivery unit, system-based FDA UDI
Device Name
ULSPIRA TS Nitric Oxide Therapy System - Base Unit and Mobile Cart FDA UDI
Model / Reference
ULSPIRA TS FDA UDI
Description
ULSPIRA TS Nitric Oxide Therapy System - Base Unit and Mobile Cart FDA UDI

Identifiers

Catalog Number
IN000102 FDA UDI
Primary DI / UDI-DI
03760333380671 FDA UDI
510(k) Number
K212409 FDA UDI
FDA Product Code
MRN FDA UDI
MRO FDA UDI
MRP FDA UDI
MRQ FDA UDI
CCL FDA UDI
GMDN Term
Nitric oxide delivery unit, system-based FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5165 FDA UDI
868.2380 FDA UDI
868.2385 FDA UDI
868.1720 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Nitric oxide delivery unit, system-based

Ulspira TS by Airgas Therapeutics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitric oxide delivery unit, system-based.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Airgas Therapeutics

Sources (1)

  • FDA UDI eae477ea-f328-48e3-a73b-44ec9c96fe53 36 fields · synced May 30, 2026