Identity
- Trade Name
- Trinity Medical Devices FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- Full Face CPAP Mask 22MM female elbow, vented Large FDA UDI
- Model / Reference
- TST102 FDA UDI
- Description
- Full Face CPAP Mask 22MM female elbow, vented Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813880025595 FDA UDI
- 510(k) Number
- K063268 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CPAP/BPAP face mask, reusable
Trinity Medical Devices by Trinity Medical Devices Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K063268 also covers:
- Classic Full Face CPAP Mask with Headgear - Large — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Classic Full Face CPAP Mask with Headgear - Medium — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Classic Full Face CPAP Mask with Headgear - Small — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Classic Nasal CPAP Mask with Headgear - Large — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Classic Nasal CPAP Mask with Headgear - Medium — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Large — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Large *No Headgear* — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Large *No Headgear* - Retail — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Medium — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Medium *No Headgear* — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Medium *No Headgear* -Retail — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Small — SUNSET HEALTHCARE SOLUTIONS, Inc.
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
- Trinity Medical Devices Inc.
Sources (1)
- FDA UDI b9eb2c92-b051-4fb9-a728-091170f10b9c 34 fields · synced May 30, 2026