FDA.reportPublic FDA data

Ulspira TS

Primary DI
03760333380671
Brand
Ulspira TS
Company
Airgas Therapeutics, LLC
Model
ULSPIRA TS
Catalog number
IN000102
Device description
ULSPIRA TS Nitric Oxide Therapy System - Base Unit and Mobile Cart
Published
2024-01-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
MRNApparatus, Nitric Oxide Delivery
MROApparatus, Nitric Oxide, Backup Delivery
MRPAnalyzer, Nitric Oxide
MRQAnalyzer, Nitrogen Dioxide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2
MRNApparatus, Nitric Oxide DeliveryAnesthesiology2
MROApparatus, Nitric Oxide, Backup DeliveryAnesthesiology2
MRPAnalyzer, Nitric OxideAnesthesiology2
MRQAnalyzer, Nitrogen DioxideAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212409000
K242374000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212409000Ulspira TS Nitric Oxide Therapy SystemAirgas Therapeutics2023-06-30MRN
K242374000ULSPIRA TS™ Nitric Oxide Therapy SystemAirgas Therapeutics, LLC2025-01-17MRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760333380671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760333380671037603333806713760333380671

GMDN Terms#

Term, Definition table
TermDefinition
Nitric oxide delivery unit, system-basedA mains electricity (AC-powered) device, which may include internal rechargeable batteries, intended for the delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of neonate, paediatric, and adult patients to treat severe respiratory disorders [e.g., primary pulmonary hypertension (PPH), acute respiratory distress syndrome (ARDS)]. It consists of a portable main unit that enables the delivery and monitoring of NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system. It typically includes accessory items (e.g., tubing, filters) and possibly a trolley (cart) for mobility.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
833-857-7472customerservice.healthcare@airliquide.com

Regulatory Flags#

DUNS number
118537769
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00819601026025Scott Medical ProductsCalibration GasZ02NI98MUDC0062026-04-16
00819601026032Scott Medical ProductsCalibration GasZ02NI99MUDC0322026-04-16
00819601025790Alcon Laboratories Inc.ISPAN80650003262026-02-19
00819601025820GANSHORN INDUSTRIESPULMONARY FUNCTION GASZ04NI61FEDC0022026-03-23
00819601025851MasimoCalibration GasZ03XE75KUD00002025-12-19
00819601025868MasimoCalibration GasZ02NI99K15A00022025-12-19
00819601025875MasimoCalibration GasZ03NI10K15A00002025-12-19
00819601025882MasimoCalibration GasZ04OX51K15A00002025-12-19
00819601025899MasimoCalibration GasZ03NI45K15A00002025-12-19
00819601025905MasimoCalibration GasZ02NI99KUD00012025-12-19
00819601025912MasimoCalibration GasZ02NI99K15A00012025-12-19
00819601025929MasimoCalibration GasZ02NI99K15A0002025-12-19
00819601025936MasimoCalibration GasZ02OX50KUD00002025-12-19
00819601025943MasimoCalibration GasZ02NI98K15A00002025-12-19
00819601025950MasimoCalibration GasZ02OX95K15A00002025-12-19
00819601025967MasimoCalibration GasZ02NI87K15A00002025-12-19
00819601025974MasimoCalibration GasZ02NI70K15A00002025-12-19
00819601025837EscalonISPANSMPQES180@V22025-11-21
00819601025769DIAMOND DIAGNOSTICSCalibration GasZ02NI908QDC0002025-07-25
00819601025776DIAMOND DIAGNOSTICSCalibration GasZ03NI835QDC0002025-07-25

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