Identity
- Trade Name
- PowerMidline FDA UDI
- Generic Name
- Peripheral vascular intervention infusion catheter FDA UDI
- Device Name
- Catheter Placement Kit FDA UDI
- Model / Reference
- CK000977 FDA UDI
- Description
- Catheter Placement Kit FDA UDI
Identifiers
- Catalog Number
- CK000977 FDA UDI
- Primary DI / UDI-DI
- 00801741202209 FDA UDI
- FDA Product Code
- PND FDA UDI
- GMDN Term
- Peripheral vascular intervention infusion catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
Yes
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Catheter Gauge — 4 French FDA UDILength — 20 Centimeter FDA UDI
Category: Peripheral vascular intervention infusion catheter
A flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region.
Similar devices
Also classified as Peripheral vascular intervention infusion catheter.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Bard Access Systems, Inc.
Sources (1)
- FDA UDI 37db2a93-d242-4979-b9fa-cf08dcb26d6a 37 fields · synced Jul 18, 2026