Identity
- Trade Name
- AMSure® Pre-Connected Urethral Tray FDA UDI
- Generic Name
- Intermittent urethral catheterization kit FDA UDI
- Device Name
- AMSure® Pre-Connected Urethral Tray Red Rubber Urethral Catheter Pre-Connected to Drainage Bag. Contents: 1200ml Drainage Bag with Pre-Connected 14 Fr Red Rubber Urethral Catheter, CSR Wrap, Waterproof Absorbent Underpad, Pre-Cuffed Nitrile Gloves (2), Fenestrated Drape, Povidone-Iodine Swabsticks (3), Package Sterile Lubricating Jelly, 2oz Specimen Container with ID Label FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSure® Pre-Connected Urethral Tray Red Rubber Urethral Catheter Pre-Connected to Drainage Bag. Contents: 1200ml Drainage Bag with Pre-Connected 14 Fr Red Rubber Urethral Catheter, CSR Wrap, Waterproof Absorbent Underpad, Pre-Cuffed Nitrile Gloves (2), Fenestrated Drape, Povidone-Iodine Swabsticks (3), Package Sterile Lubricating Jelly, 2oz Specimen Container with ID Label FDA UDI
Identifiers
- Catalog Number
- AS89214R FDA UDI
- Primary DI / UDI-DI
- 10704411003816 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
Yes
FDA UDI
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
Category: Intermittent urethral catheterization kit
AMSure® Pre-Connected Urethral Tray by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 (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 9d6d4fdb-af6b-4ec9-9be9-68536a2ea13c 34 fields · synced May 31, 2026