Identity
- Trade Name
- T-PIECE, 22M, 22M/15F, 22M, WITH ONE-WAY VALVES FDA UDI
- Generic Name
- Non-rebreathing valve, single-use FDA UDI
- Device Name
- T-PIECE, 22M, 22M/15F, 22M, WITH ONE-WAY VALVES FDA UDI
- Model / Reference
- 1954000 FDA UDI
- Description
- T-PIECE, 22M, 22M/15F, 22M, WITH ONE-WAY VALVES FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267057207 FDA UDI
- 510(k) Number
- K921512 FDA UDI
- FDA Product Code
- BZA FDA UDI
- GMDN Term
- Non-rebreathing valve, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5810 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
No
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-rebreathing valve, single-use
T-Piece, 22m, 22m/15f, 22m, With One-Way Valves by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K921512 also covers:
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intersurgical Incorporated
Sources (1)
- FDA UDI e70222f3-31fc-4b8e-902b-7ac25dc31957 35 fields · synced Jun 8, 2026