Identity
- Trade Name
- primeMidline FDA UDI
- Generic Name
- Central venous catheterization kit, short-term FDA UDI
- Device Name
- 5F (1.67mm) x 20cm Dual Lumen CT Midline FDA UDI
- Model / Reference
- PFM5DML20 FDA UDI
- Description
- 5F (1.67mm) x 20cm Dual Lumen CT Midline FDA UDI
Identifiers
- Catalog Number
- PFM5DML20 FDA UDI
- Primary DI / UDI-DI
- 00813623011625 FDA UDI
- 510(k) Number
- K173114 FDA UDI
- FDA Product Code
- PND FDA UDI
- GMDN Term
- Central venous catheterization kit, short-term 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
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
No
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
Category: Central venous catheterization kit, short-termPeripheral vascular catheter
primeMidline by Pfm Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Peripheral vascular catheter.
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- 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
Cleared under the same submission
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
- Pfm Medical Incorporated
Sources (1)
- FDA UDI 69770d42-a445-4550-a3e8-9881396a5fef 36 fields · synced May 30, 2026