Identity
- Trade Name
- Statlock IV Select Start Kit FDA UDI
- Generic Name
- Intravenous administration tubing extension set FDA UDI
- Device Name
- StatLock IV Select Macrobore 7in Bifurcated with 2 UltraSite IV Start Kit FDA UDI
- Model / Reference
- IVK0154 FDA UDI
- Description
- StatLock IV Select Macrobore 7in Bifurcated with 2 UltraSite IV Start Kit FDA UDI
Identifiers
- Catalog Number
- IVK0154 FDA UDI
- Primary DI / UDI-DI
- 00801741082580 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Intravenous administration tubing extension set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 7 Inch FDA UDI
Statlock IV Select Start Kit by Bard Access Systems, Inc. — 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
- Bard Access Systems, Inc.
Sources (1)
- FDA UDI c9e72527-939e-4c66-81a7-0568a618d6c7 38 fields · synced Jun 9, 2026