Identity
- Trade Name
- PS 54A Exhalation Valve with Water Trap FDA UDI
- Generic Name
- Non-rebreathing valve, reusable FDA UDI
- Device Name
- This reusable exhalation valve is designed for use with ventilators. The exhalation valve prevents the inspired gases from escaping through the passage that will be made available to expired gases via an inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action. FDA UDI
- Model / Reference
- PS 54A FDA UDI
- Description
- This reusable exhalation valve is designed for use with ventilators. The exhalation valve prevents the inspired gases from escaping through the passage that will be made available to expired gases via an inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M996PS54A0 FDA UDI
- 510(k) Number
- K980725 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Non-rebreathing valve, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-rebreathing valve, reusable
PS 54A Exhalation Valve with Water Trap by Instrumentation Industries, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K980725 also covers:
- BE 195-A Adapter for Exhalation Valves — INSTRUMENTATION INDUSTRIES, INCORPORATED
- BE 30-115-B Exhalation Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED
- BE 30-115-BL Low Resistance Exhalation Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED
- NS 30-115-5 Exhalation Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED
- NS 30-115-5L Low Resistance Exhalation Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED
- NS 30-115-U Exhalation Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED
- NS 30-115-UL Low Resistance Exhalation Valve — INSTRUMENTATION INDUSTRIES, INCORPORATED
- PS 54-1A Adapter for Exhalation Valves — INSTRUMENTATION INDUSTRIES, INCORPORATED
- PS 54AL Low Resistance Exhalation Valve with Water Trap — INSTRUMENTATION INDUSTRIES, INCORPORATED
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 II | Pending data |
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Manufacturer
- Manufacturer
- Instrumentation Industries, Incorporated
Sources (1)
- FDA UDI 431408a9-752f-4e24-94eb-d5ef5539e433 35 fields · synced May 29, 2026