Identity
- Trade Name
- AMSure® TUR/Bladder Irrigation Set Y-Type FDA UDI
- Generic Name
- Urological irrigation set FDA UDI
- Device Name
- AMSure® TUR/Bladder Irrigation Set Y-Type 90" (2886 mm) Overall Length/0.27" (6.8 mm) I.D. Non-Pyrogenic FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSure® TUR/Bladder Irrigation Set Y-Type 90" (2886 mm) Overall Length/0.27" (6.8 mm) I.D. Non-Pyrogenic FDA UDI
Identifiers
- Catalog Number
- ABL402 FDA UDI
- Primary DI / UDI-DI
- 10704411005476 FDA UDI
- FDA Product Code
- LJH FDA UDI
- GMDN Term
- Urological irrigation set 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: Urological irrigation set
AMSure® TUR/Bladder Irrigation Set Y-Type by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urological irrigation set.
- Cook CollectEVAC — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Multiphze Enclosed Bladder Irrigation System — Multiphze, LLC · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- MED-RX — Canadian Hospital Specialties Limited · Class II
- NURSE ASSIST — NURSE ASSIST, INC. · Class I
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- MED-RX — Canadian Hospital Specialties Limited · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class I
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 ab6fdae7-763c-41f3-acfe-f8910b9558fa 34 fields · synced May 30, 2026