Identity
- Trade Name
- Cook Spectrum Turbo-Ject FDA UDI
- Generic Name
- Peripherally-inserted central venous catheter FDA UDI
- Device Name
- Cook Spectrum Turbo-Ject PICC Set Minocycline/Rifampin Impregnated Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter FDA UDI
- Model / Reference
- G56198 FDA UDI
- Description
- Cook Spectrum Turbo-Ject PICC Set Minocycline/Rifampin Impregnated Power Injectable Polyurethane Peripherally Inserted Central Venous Catheter FDA UDI
Identifiers
- Catalog Number
- UPICS-4.0-CT-OTW-ST-ABRM-1110 FDA UDI
- Primary DI / UDI-DI
- 00827002561984 FDA UDI
- FDA Product Code
- LJS FDA UDI
- GMDN Term
- Peripherally-inserted central venous catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5970 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Cook Spectrum Turbo-Ject by Cook Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cook Incorporated
Sources (1)
- FDA UDI 3cc092af-f30d-49f1-9a51-d71a58cfd643 37 fields · synced Jun 8, 2026