Identity
- Trade Name
- Suction Catheter Kit FDA UDI
- Generic Name
- Tracheostomy suction kit FDA UDI
- Device Name
- This kit includes: 1 Catheter - 8Fr, Y-Valve, 1 Pair gloves - One size fits most. FDA UDI
- Model / Reference
- TRATK108 FDA UDI
- Description
- This kit includes: 1 Catheter - 8Fr, Y-Valve, 1 Pair gloves - One size fits most. FDA UDI
Identifiers
- Catalog Number
- TRATK108 FDA UDI
- Primary DI / UDI-DI
- 00848530082062 FDA UDI
- FDA Product Code
- OFS FDA UDI
- GMDN Term
- Tracheostomy suction kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tracheostomy suction kit
Suction Catheter Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheostomy suction kit.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
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 598c5fca-be6b-4d55-8eed-df097095044d 35 fields · synced Jun 8, 2026