Identity
- Trade Name
- PS 54-1A Adapter for Exhalation Valves FDA UDI
- Generic Name
- Non-rebreathing valve, reusable FDA UDI
- Device Name
- This adapter connects to the exhalation valve for additional versatility. FDA UDI
- Model / Reference
- PS 54-1A FDA UDI
- Description
- This adapter connects to the exhalation valve for additional versatility. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M996PS541A0 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 54-1A Adapter for Exhalation Valves 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 54A Exhalation Valve with Water Trap — 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 a49ea774-8776-48ef-a089-b5bcd3d8bcf9 35 fields · synced Jun 1, 2026