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AMSure® Urethral Self Catheterization Kit

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref AS85014

by Amsino International, Inc.

Identity

Trade Name
AMSure® Urethral Self Catheterization Kit EUDAMEDFDA UDI
Generic Name
Intermittent urethral catheterization kit FDA UDI
Device Name
Closed system self-catheterization 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
Model / Reference
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

Identifiers

Catalog Number
AS85014 FDA UDI
Primary DI / UDI-DI
10704411003588 EUDAMEDFDA UDI
Basic UDI-DI
B-10704411003588 EUDAMED
FDA Product Code
FCM FDA UDI
EMDN Code
U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
GMDN Term
Intermittent urethral catheterization kit FDA UDI

Classification

Device Class
Class I 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

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

Yes

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

AMSure® Urethral Self Catheterization Kit by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Amsino International, Inc.

Sources (2)

  • FDA UDI b21d0980-c499-47b1-862f-f0dc25dc386f 34 fields · synced Oct 7, 2026
  • EUDAMED 576955ae-db72-42ad-a667-26314c4f1cd6 61 fields · synced Aug 3, 2026