Identity
- Trade Name
- Fast Track FDA UDI
- Generic Name
- Subcutaneous tunneller, single-use FDA UDI
- Device Name
- Fast Track Tunneler Set, 15" and 6" FDA UDI
- Model / Reference
- 42-3500 FDA UDI
- Description
- Fast Track Tunneler Set, 15" and 6" FDA UDI
Identifiers
- Catalog Number
- 42-3500 FDA UDI
- Primary DI / UDI-DI
- 10885403193521 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- Subcutaneous tunneller, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Subcutaneous tunneller, single-use
Fast Track by Carefusion 2200, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- AVANOS — Avanos Medical, Inc. · Class II
- Halyard — Avanos Medical, Inc. · Class II
- Mainstay Tunneler — MAINSTAY MEDICAL LIMITED · Class III
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
- Carefusion 2200, Inc.
Sources (1)
- FDA UDI fa634ef8-7c12-4546-80fb-13610efd1afe 35 fields · synced Sep 18, 2026