Identity
- Trade Name
- Procure FDA UDI
- Generic Name
- Tracheostomy tube neck holder, single-use FDA UDI
- Device Name
- Trach Tie Small, Foam w/moisture repellent backing, 1 Piece, L 9.5" x W 1.25" FDA UDI
- Model / Reference
- 1003520 FDA UDI
- Description
- Trach Tie Small, Foam w/moisture repellent backing, 1 Piece, L 9.5" x W 1.25" FDA UDI
Identifiers
- Catalog Number
- 1003520 FDA UDI
- Primary DI / UDI-DI
- 10840330700693 FDA UDI
- FDA Product Code
- CBH FDA UDI
- GMDN Term
- Tracheostomy tube neck holder, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5770 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Length — 9.5 Inch FDA UDIWidth — 1.25 Inch FDA UDI
Category: Tracheostomy tube neck holder, single-use
Procure by Twin Med, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube neck holder, single-use.
- Vent Tie — PEPPER MEDICAL, INC. · Class I
- Trach Tie — PEPPER MEDICAL, INC. · Class I
- Provox Life LP Kit 12 - LT 12/36, 12/55 — ATOS MEDICAL INC. · Class II
- Trach Tie — PEPPER MEDICAL, INC. · Class I
- Trach Tie — PEPPER MEDICAL, INC. · Class I
- Dr Zee — Resp Devices LLC · Class I
- Marpac Inc — Marpac, Inc. · Class I
- Resp-O2 Soft-Foam Trach Tube Holder, 1 PC, Adult, 22" Length — Dynarex Corp. · Class I
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
- Twin Med, LLC
Sources (1)
- FDA UDI 7678d309-ee1d-4d9d-a798-2690f9127215 36 fields · synced May 30, 2026