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AMSure® Foley Insertion Tray
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AS890Ref AS880KRef AS890KRef AS880
Identity
- Trade Name
- AMSure® Foley Insertion Tray EUDAMEDFDA UDI
- Generic Name
- Intermittent urethral catheterization kit FDA UDI
- Device Name
- Urinary Catheterization/ Collection Kit EUDAMEDAMSure® Foley Insertion Tray CONTENTS: Color: Pantone 293c 1 each 1000mL Outer Basin Tray 1 each Prefilled 10cc Syringe of Sterile Water 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 pack PVP Swabsticks (3) FDA UDIAMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray, 1 each Prefilled 10cc Syringe of Sterile Water, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks FDA UDIAMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray, 1 each Prefilled 30cc Syringe of Sterile Water, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks FDA UDIAMSure® Foley Insertion Tray CONTENTS: 1 each 1000 mL Outer Basin Tray 1 each Prefilled 30 mL Syringe of Sterile Water 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly FDA UDIAMSure® Foley Insertion Tray CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 1000 mL Outer Basin Tray 1 each Prefilled 10 mL Syringe of Sterile Water 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly NON-STERILE CONTENT: 1 pack BZK Swabsticks (3) FDA UDI
- Model / Reference
- AS890 EUDAMEDAS880K EUDAMEDAS890K EUDAMEDAS880 EUDAMED1 FDA UDI
- Description
- AMSure® Foley Insertion Tray CONTENTS: Color: Pantone 293c 1 each 1000mL Outer Basin Tray 1 each Prefilled 10cc Syringe of Sterile Water 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly 1 pack PVP Swabsticks (3) FDA UDIAMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray, 1 each Prefilled 10cc Syringe of Sterile Water, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks FDA UDIAMSure® Foley Insertion Tray CONTENTS: 1 each 1000mL Outer Basin Tray, 1 each Prefilled 30cc Syringe of Sterile Water, 1 pair Vinyl Gloves, 1 each Waterproof Drape, 1 each Fenestrated Drape, 1 pack Lubricating Jelly, 3 each PVP Swabsticks FDA UDIAMSure® Foley Insertion Tray CONTENTS: 1 each 1000 mL Outer Basin Tray 1 each Prefilled 30 mL Syringe of Sterile Water 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly FDA UDIAMSure® Foley Insertion Tray CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each 1000 mL Outer Basin Tray 1 each Prefilled 10 mL Syringe of Sterile Water 1 pair Vinyl Gloves 1 each Waterproof Drape 1 each Fenestrated Drape 1 pack Lubricating Jelly NON-STERILE CONTENT: 1 pack BZK Swabsticks (3) FDA UDI
Identifiers
- Catalog Number
- AS880-02 FDA UDIAS880 FDA UDIAS890 FDA UDIAS890K FDA UDIAS880K FDA UDI
- Primary DI / UDI-DI
- 10704411002383 EUDAMEDFDA UDI10704411002390 EUDAMEDFDA UDI10704411007623 EUDAMEDFDA UDI10704411007616 EUDAMEDFDA UDI10704411008026 FDA UDI
- Basic UDI-DI
- B-10704411002390 EUDAMEDB-10704411007616 EUDAMEDB-10704411007623 EUDAMEDB-10704411002383 EUDAMED
- FDA Product Code
- FCM FDA UDI
- EMDN Code
- U99 DEVICES FOR UROGENITAL SYSTEM - OTHER EUDAMED
- GMDN Term
- Intermittent urethral catheterization kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass 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
No
FDA UDIFDA UDI
Combination Product
No
FDA UDIFDA 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: Intermittent urethral catheterization kit
AMSure® Foley Insertion Tray by Amsino International, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 (9)
- FDA UDI 9d24c2a2-af66-4a6a-93df-bb92e2bb8cf7 34 fields · synced Jul 20, 2026
- FDA UDI 1e46f8e8-f00d-4dff-aa28-a49afea05805 34 fields · synced May 30, 2026
- FDA UDI 1a91d6a7-7a70-4cb5-8922-d66445eeb7a6 34 fields · synced May 30, 2026
- FDA UDI 3fa46077-44da-4c13-bbe4-52dcf7f68767 34 fields · synced May 30, 2026
- FDA UDI dd282bec-c97e-472b-9ee9-1302565f1725 34 fields · synced May 30, 2026
- EUDAMED 32d1bc92-10c0-4e74-a9d7-535286d9dc6b 61 fields · synced Jul 11, 2026
- EUDAMED 332b02c6-123f-4b01-87a6-a44678ba1b73 61 fields · synced Jul 12, 2026
- EUDAMED 04626aa3-fcd3-4496-9e46-a7c3a7c25992 61 fields · synced Jul 12, 2026
- EUDAMED f8128730-edcd-40ac-96d1-6ba9b7677011 61 fields · synced Jul 20, 2026