Pro-Fuse® Low Profile CT Port

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name: Pro-Fuse® Low Profile CT Port FDA UDI
Generic Name: Vascular port/catheter FDA UDI
Device Name: 8F PLASTIC Pro-Fuse® LOW PROFILE CT PORT W/SILICONE FILLED SUTURE HOLES W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER FDA UDI
Model / Reference: MRPP80ALS FDA UDI
Description: 8F PLASTIC Pro-Fuse® LOW PROFILE CT PORT W/SILICONE FILLED SUTURE HOLES W/ATTACHABLE ChronoFlex® POLYURETHANE CATHETER FDA UDI

Identifiers

Primary DI / UDI-DI: 00884908109771 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

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Vascular port/catheter

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

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Also classified as Vascular port/catheter.

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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: Medical Components Inc

Sources (1)

FDA UDI 51c0cf78-83ca-48b2-b5d5-a162c690d495 34 fields · synced Jun 8, 2026