Grafco

FDA UDI

Class I (US FDA UDI)

by GF Health Products, Inc

Identity

Trade Name: Grafco FDA UDI
Generic Name: Peritoneal drainage catheter FDA UDI
Device Name: TUBING PENROSE DRAIN5/8" 25/BX FDA UDI
Model / Reference: 3953 5/8 FDA UDI
Description: TUBING PENROSE DRAIN5/8" 25/BX FDA UDI

Identifiers

Catalog Number: 3953 5/8 FDA UDI
Primary DI / UDI-DI: M3683953581 FDA UDI
FDA Product Code: GBW FDA UDI
GMDN Term: Peritoneal drainage catheter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4200 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Dimensions & Sizes

Size: Catheter Inner Diameter — .625 Inch FDA UDI

Category: Peritoneal drainage catheter

Grafco by GF Health Products, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Peritoneal drainage catheter.

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ACCEL® — B. BRAUN MEDICAL INC. · Class I
ACCEL® — B. BRAUN MEDICAL INC. · Class I
TAUT — TELEFLEX INCORPORATED · Class I
TAUT — TELEFLEX INCORPORATED · Class I
ACCEL™ — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: GF Health Products, Inc

Sources (1)

FDA UDI 6ec08603-9d7e-4c09-84d0-eef3c2c6f928 36 fields · synced May 30, 2026