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Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in) FDA UDI
- Generic Name
- Tracheostomy tube neck holder, single-use FDA UDI
- Device Name
- Pediatric Two Piece Trach Ties, 2x35.5cm (14in) - 20/box FDA UDI
- Model / Reference
- RES030P-14 FDA UDI
- Description
- Pediatric Two Piece Trach Ties, 2x35.5cm (14in) - 20/box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530103552 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
No
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
Category: Tracheostomy tube neck holder, single-use
Two Piece Tracheostomy Tie Pediatric 2cm x 35.5cm (14in) by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID
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 |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 073758e7-3390-4fde-9cf4-8166a277ab25 33 fields · synced May 30, 2026