Identity
- Trade Name
- ACCEL Centesis Catheter FDA UDI
- Generic Name
- Peripheral vascular catheter FDA UDI
- Device Name
- 4F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage FDA UDI
- Model / Reference
- 613211 FDA UDI
- Description
- 4F x 10cm ACCEL Centesis Catheter Percutaneous Fluid Drainage FDA UDI
Identifiers
- Catalog Number
- 613211 FDA UDI
- Primary DI / UDI-DI
- 00813623011427 FDA UDI
- FDA Product Code
- GCB FDA UDI
- GMDN Term
- Peripheral vascular catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 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: Peripheral vascular catheter
ACCEL Centesis Catheter by Pfm Medical Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular catheter.
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- EXEL Safelet Catheter — Exel International · Class II
- Jelco — ICU MEDICAL, INC. · Class II
- DELTAVEN — DELTA MED SPA · Class II
- EXEL Safelet Catheter — Exel International · Class II
- POWERWAND — ICU MEDICAL, INC. · Class II
- POWERWAND — Access Scientific, Inc. · Class II
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
- Pfm Medical Incorporated
Sources (1)
- FDA UDI 603b9989-bf0c-4b3f-ba1e-df01d5a0b78c 35 fields · synced Jun 1, 2026