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I-SERIES PD Catheter

FDA UDI

Class II (US FDA UDI)

by Medical Components Inc

Identity

Trade Name
I-SERIES PD Catheter FDA UDI
Generic Name
Peritoneal dialysis catheter, acute/chronic FDA UDI
Device Name
15F X 60CM I-SERIES COILED PERITONEAL DIALYSIS CATHETER SET W/1 CUFF FDA UDI
Model / Reference
MC20IC60PS FDA UDI
Description
15F X 60CM I-SERIES COILED PERITONEAL DIALYSIS CATHETER SET W/1 CUFF FDA UDI

Identifiers

Primary DI / UDI-DI
00884908092448 FDA UDI
FDA Product Code
FJS FDA UDI
GMDN Term
Peritoneal dialysis catheter, acute/chronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5630 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

Category: Peritoneal dialysis catheter, acute/chronic

I-SERIES PD Catheter by Medical Components Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peritoneal dialysis catheter, acute/chronic.

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 2beecccd-c5a9-4e28-8af9-6652164534bd 34 fields · synced May 30, 2026