Identity
- Trade Name
- AMSure® Preconnected Urethral Tray FDA UDI
- Generic Name
- Intermittent urethral catheterization kit FDA UDI
- Device Name
- – 1200ml Drainage Bag with Pre-Connected 14 Fr Vinyl Urethral Catheter(China) – CSR Wrap(China)– Waterproof Absorbent Underpad(China) – Pre-Cuffed Nitrile Gloves (2)(China) – Fenestrated Drape(China) – Povidone-Iodine Swabsticks (3)(China) – Package Sterile Lubricating Jelly(USA) – 2oz Specimen Container with ID Label(China) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- – 1200ml Drainage Bag with Pre-Connected 14 Fr Vinyl Urethral Catheter(China) – CSR Wrap(China)– Waterproof Absorbent Underpad(China) – Pre-Cuffed Nitrile Gloves (2)(China) – Fenestrated Drape(China) – Povidone-Iodine Swabsticks (3)(China) – Package Sterile Lubricating Jelly(USA) – 2oz Specimen Container with ID Label(China) FDA UDI
Identifiers
- Catalog Number
- AS89214 FDA UDI
- Primary DI / UDI-DI
- 10704411017776 FDA UDI
- FDA Product Code
- FCM FDA UDI
- GMDN Term
- Intermittent urethral catheterization kit 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
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
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
Category: Intermittent urethral catheterization kit
AMSure® Preconnected Urethral 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.
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- 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 (2)
- FDA UDI a123b63a-4d07-4c16-bc93-d174d14f49e0 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026