Identity
- Trade Name
- AMSure ® Add-A-Foley Tray FDA UDI
- Generic Name
- Intermittent urethral drainage catheter, non-antimicrobial, single-use FDA UDI
- Device Name
- 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hanger Bed sheet clamp T-valve drainage outlet Air vent AMSafe® needleless sampling port 10 mL Pre-Filled Syringe with Sterile Water (China) FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 400mL Urine Meter attached to 2600mL Drainage Bag (China) with: Universal hook hanger Bed sheet clamp T-valve drainage outlet Air vent AMSafe® needleless sampling port 10 mL Pre-Filled Syringe with Sterile Water (China) FDA UDI
Identifiers
- Catalog Number
- AS89800 FDA UDI
- Primary DI / UDI-DI
- 10704411014881 FDA UDI
- FDA Product Code
- FCM FDA UDI
- GMDN Term
- Intermittent urethral drainage catheter, non-antimicrobial, single-use 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
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 drainage catheter, non-antimicrobial, single-use
AMSure ® Add-A-Foley Tray by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral drainage catheter, non-antimicrobial, single-use.
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- hi-slip plus — Wellspect HealthCare · Class I
- TruCath Oasis — H R Pharmaceuticals, Inc. · Class II
- SmoothCath™ — GELİŞİM MEDİKAL TIBBİ MALZ. PAZ. SAN. VE TİC. LTD. ŞTİ. · Class I
- PVC Hydrophilic Urethral Catheter — Chengdu Daxan Innovative Medical Tech. Co., Ltd. · Class II
- Sterile Urinary Catheter for single use — Jiangsu Suyun Medical Materials Co., Ltd. · Class IIa
- BeneCath® — Hangzhou Jimushi Meditech Co., Ltd. · Class II
- CompactCath Nelaton, Female, 14 Fr/Ch, 19cm — Lentismed d.o.o. · 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 09295006-1b80-48eb-aa80-b284b6585456 34 fields · synced Jun 1, 2026