Identity
- Trade Name
- Technical Products FDA UDI
- Generic Name
- Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI
- Device Name
- T-tube FDA UDI
- Model / Reference
- TP-08T FDA UDI
- Description
- T-tube FDA UDI
Identifiers
- Primary DI / UDI-DI
- B051TP08T1 FDA UDI
- 510(k) Number
- K013321 FDA UDI
- FDA Product Code
- BTR FDA UDI
- GMDN Term
- Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5730 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
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 8 Millimeter FDA UDI
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
Technical Products by Technical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tracheostomy tube, non-reinforced, non-customized, single-use.
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Cleared under the same submission
K013321 also covers:
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, INC.
- Technical Products — TECHNICAL PRODUCTS, 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
- Technical Products, Inc.
Sources (1)
- FDA UDI ed70dace-06e5-4e81-8a5e-83670ff801b4 35 fields · synced May 30, 2026