Identity
- Trade Name
- Trach Tie FDA UDI
- Generic Name
- Tracheostomy tube neck holder, single-use FDA UDI
- Device Name
- Adult Trach Tube Holder FDA UDI
- Model / Reference
- 540 FDA UDI
- Description
- Adult Trach Tube Holder FDA UDI
Identifiers
- Catalog Number
- 540 FDA UDI
- Primary DI / UDI-DI
- 00850014574246 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Tracheostomy tube neck holder, single-use
Trach Tie by Pepper Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy tube neck holder, single-use.
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- 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
- Provox Life LP Kit 16 - LT 10/55-2HSTP — ATOS MEDICAL INC. · Class II
- Provox Life LP Kit 1 - LT 8/36, 8/55 — ATOS MEDICAL INC. · Class II
- Tracheostomy Tube Neckband 2-Piece with Fastener Tabs - Adult — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Two Piece Tracheostomy Tie Adult 2.5cm x 51cm (20in) — SUNSET HEALTHCARE SOLUTIONS, Inc. · 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 |
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Manufacturer
- Manufacturer
- Pepper Medical, Inc.
Sources (1)
- FDA UDI 445f698f-3a13-46db-8c98-097c41f11347 35 fields · synced May 30, 2026