AMSure® Urethral Self Catheterization Kit

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref AS85010Ref AS85016KRef AS85012KRef AS85008Ref AS85014

by Amsino International, Inc.

Identity

Trade Name: AMSure® Urethral Self Catheterization Kit EUDAMEDFDA UDI
AMSure® Urethral Self Catheterization Kit 12Fr. FDA UDI
AMSure® Urethral Self Catheterization Kit 16Fr. FDA UDI
Generic Name: Intermittent urethral catheterization kit FDA UDI
Device Name: Closed system self-catheterization kit EUDAMED
Urinary Catheterization/ Collection Kit EUDAMED
AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System CONTENTS: 1 Pre-lubricated PVC Urethral Catheter, 16" (40cm) Length, 1 1100ml Collection Bag with Insertion Tip, 3 Povidone-Iodine Swabsticks, 1 Benzalkonium Chloride Prep Pad, 2 Cuffed Vinyl Gloves, 1 Warerproof Underpad, 13" × 18" (340 × 450 mm), 1 Waste Disposal Bag, 1 Gauze Pad, 4" × 4" (100 × 100 mm) FDA UDI
AMSure® Urethral Self Catheterization Kit 12Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad FDA UDI
AMSure® Urethral Self Catheterization Kit 16Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad FDA UDI
Model / Reference: AS85010 EUDAMED
AS85016K EUDAMED
AS85012K EUDAMED
AS85008 EUDAMED
AS85014 EUDAMED
1 FDA UDI
Description: AMSure® Urethral Self Catheterization Kit with RPOLISHED® Eyes, Pre-lubricated, Closed System CONTENTS: 1 Pre-lubricated PVC Urethral Catheter, 16" (40cm) Length, 1 1100ml Collection Bag with Insertion Tip, 3 Povidone-Iodine Swabsticks, 1 Benzalkonium Chloride Prep Pad, 2 Cuffed Vinyl Gloves, 1 Warerproof Underpad, 13" × 18" (340 × 450 mm), 1 Waste Disposal Bag, 1 Gauze Pad, 4" × 4" (100 × 100 mm) FDA UDI
AMSure® Urethral Self Catheterization Kit 12Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad FDA UDI
AMSure® Urethral Self Catheterization Kit 16Fr. with • Pre-lubricated • Closed System CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each Pre-lubricated PVC Urethral Catheter, 16” (40 cm) Length 1 each 1100 mL Collection Bag with Insertion Tip 1 each Waterproof Underpad, 13”x18” (340 x 450 mm) 1 pair Cuffed Vinyl Gloves 1 each Waste Disposal Bag 1 each Gauze Pad, 4”x4”(100 x 100 mm) NON-STERILE CONTENTS: 1 pack BZK Swabsticks (3) 1 pack Benzalkonium Chloride Prep Pad FDA UDI

Identifiers

Catalog Number: AS85010 FDA UDI
AS85012K FDA UDI
AS85016K FDA UDI
AS85008 FDA UDI
AS85014 FDA UDI
Primary DI / UDI-DI: 10704411003564 EUDAMEDFDA UDI
10704411007579 EUDAMEDFDA UDI
10704411007593 EUDAMEDFDA UDI
10704411003557 EUDAMEDFDA UDI
10704411003588 EUDAMEDFDA UDI
Basic UDI-DI: B-10704411003564 EUDAMED
B-10704411007593 EUDAMED
B-10704411007579 EUDAMED
B-10704411003557 EUDAMED
B-10704411003588 EUDAMED
FDA Product Code: FCM FDA UDI
EMDN Code: U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
GMDN Term: Intermittent urethral catheterization kit FDA UDI

Classification

Device Class: Class I EUDAMED
Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 876.5130 FDA UDI
Market of Registration: Netherlands EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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: Intermittent urethral catheterization kit

A comprehensive and accurate medical device directory entry for the AMSure Urethral Self Catheterization Kit.

Similar devices

Also classified as Intermittent urethral catheterization kit.

TruCath — H R Pharmaceuticals, Inc. · Class II
O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
GLOBAL HEALTHCARE — GHC HEALTHCARE, INC. · Class II
MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
TruCath — H R Pharmaceuticals, Inc. · Class II
O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD. · Class II
TruCath — H R Pharmaceuticals, Inc. · Class II

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Amsino International, Inc.

Sources (10)

FDA UDI c4f1a49b-56cd-4173-926e-657bef8290f2 34 fields · synced Aug 3, 2026
FDA UDI d55c609e-ed33-4a10-a863-235674cb1dd3 34 fields · synced May 29, 2026
FDA UDI b4854815-0e0e-42c6-b1f8-2e26fd9bd0a6 34 fields · synced May 29, 2026
FDA UDI 98980788-e07c-4f53-9606-3adb975b22b0 34 fields · synced May 30, 2026
FDA UDI b21d0980-c499-47b1-862f-f0dc25dc386f 34 fields · synced May 30, 2026
EUDAMED 6d0235a7-270b-4652-9525-b3be04c98950 61 fields · synced Jul 12, 2026
EUDAMED af2f0fd4-6bea-459d-9a35-11c69e558e75 61 fields · synced Jul 15, 2026
EUDAMED 80444972-aa7f-4f4c-99e1-844d46164710 61 fields · synced Jul 18, 2026
EUDAMED d5aa8635-d4b5-47b9-8ceb-121bd7f5f3d8 61 fields · synced Jul 30, 2026
EUDAMED 576955ae-db72-42ad-a667-26314c4f1cd6 61 fields · synced Aug 3, 2026