Identity
- Trade Name
- Tita Jet FDA UDI
- Generic Name
- Vascular port/catheter FDA UDI
- Device Name
- 4.8F Tita Jet Light Low Profile HP PUR Kit FDA UDI
- Model / Reference
- 616.360.9070-HAV FDA UDI
- Description
- 4.8F Tita Jet Light Low Profile HP PUR Kit FDA UDI
Identifiers
- Catalog Number
- 616.360.9070-HAV FDA UDI
- Primary DI / UDI-DI
- 00813623010413 FDA UDI
- FDA Product Code
- PXK FDA UDI
- GMDN Term
- Vascular port/catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5965 FDA UDI
- Commercial Distribution
- 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
Yes
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
MR Conditional FDA UDI
Category: Vascular port/catheter
Tita Jet by Pfm Medical Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Vascular port/catheter.
- Deltec — ICU MEDICAL, INC. · Class II
- PowerPort M.R.I., ChronoFlex — Bard Access Systems, Inc. · Class II
- PowerPort M.R.I., ChronoFlex — Bard Access Systems, Inc. · Class II
- PowerPort M.R.I. — Bard Access Systems, Inc. · Class II
- Vital-Port — COOK INCORPORATED · Class II
- Vortex — NAVILYST MEDICAL, INC. · Class II
- PowerPort — Bard Access Systems, Inc. · Class II
- Deltec — ICU MEDICAL, 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 II | Pending data |
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Manufacturer
- Manufacturer
- Pfm Medical Incorporated
Sources (1)
- FDA UDI 2d75d7e7-9591-47bd-a36d-7a1f05327da2 35 fields · synced Jun 1, 2026