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Pro-Fuse®

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
PRO-FUSE® FDA UDI
Generic Name
Vascular port/catheter FDA UDI
Device Name
8F PLASTIC Pro-Fuse® LOW PROFILE CT PORTLOW PROFILE C W/SILICONE FILLED SUTUREW/SILICO HOLES W/PRE-ATTACHEDHOLES W/PRE- ChronoFlex®POLYURETHANE CATHETERCATHETER FDA UDI
Model / Reference
MRPP80PLS FDA UDI
Description
8F PLASTIC Pro-Fuse® LOW PROFILE CT PORTLOW PROFILE C W/SILICONE FILLED SUTUREW/SILICO HOLES W/PRE-ATTACHEDHOLES W/PRE- ChronoFlex®POLYURETHANE CATHETERCATHETER FDA UDI

Identifiers

Catalog Number
MRPP80PLS FDA UDI
Primary DI / UDI-DI
00884908147476 FDA UDI
FDA Product Code
LJT 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Vascular port/catheter

Pro-Fuse® by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular port/catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medical Components Inc

Sources (1)

  • FDA UDI 0593eeb5-e7c0-4ee3-b8b4-3f5c6e73a43a 35 fields · synced Jun 8, 2026