Identity
- Trade Name
- LungFit PH Breathing Circuit 1 Kit FDA UDI
- Generic Name
- Nitric oxide delivery unit, system-based FDA UDI
- Device Name
- Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line. FDA UDI
- Model / Reference
- 80013 FDA UDI
- Description
- Nitric oxide (NO) is generated by the LungFit PH from room air just prior to delivery into an attached breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the breathing circuit just prior to inhalation by the patient, via a sampling line. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B882800130 FDA UDI
- PMA Number
- P200044 FDA UDI
- FDA Product Code
- QTB FDA UDI
- GMDN Term
- Nitric oxide delivery unit, system-based FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Nitric oxide delivery unit, system-based
LungFit PH Breathing Circuit 1 Kit by Beyond Air, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Beyond Air, Inc.
Sources (1)
- FDA UDI aceed9d2-f209-4d4a-b95b-0d6e701f49d9 35 fields · synced Jun 8, 2026