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 14 Fr. Red Rubber Urethral Catheter Pre-Connected to Drainage Bag 1 each 1200 mL Drainage Bag with Pre-Connected 14 Fr. Red Rubber Urethral Catheter CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each CSR Wrap 1 each Waterproof Absorbent Underpad 1 pair Pre-Cuffed Nitrile Gloves 1 each Fenestrated Drape 1 pack Package Sterile Lubricating Jelly 1 each 2 oz Specimen Container with ID Label NON-STERILE CONTENT: 1 pack BZK Swabsticks (3) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSure® Pre-Connected Urethral Tray 14 Fr. Red Rubber Urethral Catheter Pre-Connected to Drainage Bag 1 each 1200 mL Drainage Bag with Pre-Connected 14 Fr. Red Rubber Urethral Catheter CONTENTS STERILIZED USING ETHYLENE OXIDE: 1 each CSR Wrap 1 each Waterproof Absorbent Underpad 1 pair Pre-Cuffed Nitrile Gloves 1 each Fenestrated Drape 1 pack Package Sterile Lubricating Jelly 1 each 2 oz Specimen Container with ID Label NON-STERILE CONTENT: 1 pack BZK Swabsticks (3) FDA UDI
Identifiers
- Catalog Number
- AS89214K FDA UDI
- Primary DI / UDI-DI
- 10704411007548 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
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 (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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (1)
- FDA UDI 3ba81143-1c33-4b31-985f-9e20299a4e90 34 fields · synced May 31, 2026