LungFit PH
Basic Information
- Brand Name
- LungFit PH
- Primary DI
- B882900020
- Version / Model
- 90002
- Company Name
- Beyond Air, Inc.
- Labeler DUNS
- 080243711
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-04
- Public Version
- 1
- Public Version Date
- 2022-08-12
- Public Version Status
- New
- Public Device Record Key
- dd24eec5-a1a9-4b5b-9e9e-e2862660d8c8
Device Description
LungFit PH Product Description The LungFit PH System generates nitric oxide (NO) from room air and delivers it to a mechanical ventilator breathing circuit in a controlled concentration from 0.1 to 80 ppm NO. The attached nitric oxide delivery module (NDM) measures the gas flow in the ventilator breathing circuit and delivers a controlled flow of nitric oxide enriched gas into the 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 ventilator breathing circuit just prior to inhalation by the patient, via a sampling line. The system is comprised of three sub-systems: The NO Generator with the NO2 Filter, the Nitric Oxide Backup and Bagging System, and the Gas Sampling and Monitoring System.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QTB | Nitric Oxide Generator And Delivery System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46319 | Nitric oxide delivery system, secondary | An assembly of devices dedicated to the short-term delivery of precise amounts of nitric oxide (NO), also known as nitrogen monoxide, to the respiratory tract of patients for the treatment of severe respiratory failure, particularly when a primary delivery system cannot be used (functions as a backup system). It typically includes a computerized main unit that delivers NO to gases that are to be breathed by the patient via a ventilator or other respiratory device/system and which also monitors this gaseous mixture, and tubing. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B882900020 | HIBCC |
Customer Contacts
- Phone
- 1-855-586-4359
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P200044 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 60 Degrees Celsius
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 375 – 800 Millimeter of Mercury
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 95 Percent (%) Relative Humidity