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Cortrak*2 Enteral Access System-Smart Receiver Unit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Cortrak*2 Enteral Access System-Smart Receiver Unit FDA UDI
- Generic Name
- Subcutaneous tunneller, single-use FDA UDI
- Device Name
- CORTRAK 2 Enteral Access System-Refurbished FDA UDI
- Model / Reference
- 47212 FDA UDI
- Description
- CORTRAK 2 Enteral Access System-Refurbished FDA UDI
Identifiers
- Catalog Number
- P20-0952 FDA UDI
- Primary DI / UDI-DI
- 10680651472127 FDA UDI
- FDA Product Code
- KNT FDA UDI
- GMDN Term
- Subcutaneous tunneller, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Subcutaneous tunneller, single-use
Cortrak*2 Enteral Access System-Smart Receiver Unit by Avanos Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Subcutaneous tunneller, single-use.
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Avanos Medical, Inc.
Sources (1)
- FDA UDI a409aa9f-44fa-4507-80d3-90f7d9d39b48 35 fields · synced Jun 9, 2026