AMSure® Foley Catheter Tray

FDA UDI

Class II (US FDA UDI)

by Amsino International, Inc.

Identity

Trade Name: AMSure® Foley Catheter Tray FDA UDI
Generic Name: Indwelling urethral catheterization kit, adult FDA UDI
Device Name: "•100% Silicone Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)" FDA UDI
Model / Reference: 1 FDA UDI
Description: "•100% Silicone Foley Catheter (sterilized using ethylene oxide) (China) •FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •Wrap, Drape, Fenestrated Drape (sterilized using ethylene oxide) (China) •Catheter Lubricating Jelly Sachet 5g (sterilized using irradiation) (USA) •Nitrile Gloves (2)(sterilized using ethylene oxide) (China) •Forceps (sterilized using ethylene oxide) (China) •benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using irradiation) (China) •Specimen Container, Lid and Label (sterilized using ethylene oxide) (China)" FDA UDI

Identifiers

Catalog Number: AS89916S FDA UDI
Primary DI / UDI-DI: 10704411019671 FDA UDI
FDA Product Code: FCM FDA UDI
GMDN Term: Indwelling urethral catheterization kit, adult FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.5130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

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

Category: Indwelling urethral catheterization kit, adult

AMSure® Foley Catheter Tray by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Indwelling urethral catheterization kit, adult.

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NURSE ASSIST — NURSE ASSIST, 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: Amsino International, Inc.

Sources (1)

FDA UDI 1fa4578d-c86e-4e7f-8517-07673b66eb62 34 fields · synced May 30, 2026