Identity
- Trade Name
- AMSure® Foley Catheter Tray FDA UDI
- Generic Name
- Urethral catheterization support kit, urinary drainage FDA UDI
- Device Name
- "•FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •1000mL Outer Basin Tray (sterilized using ethylene oxide) (China) •Benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using ethylene oxide) (China) •Vinyl Gloves (sterilized using ethylene oxide) (China) •Waterproof Drape (sterilized using ethylene oxide) (China) •Fenestrated Drape (sterilized using ethylene oxide) (China) •Lubricating Jelly (sterilized using ethylene oxide) (USA) •PVP Swabsticks (sterilized using ethylene oxide) (China)" FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- "•FlexGRIP for Foley 11-18 Fr (sterilized using irradiation) (Poland) •1000mL Outer Basin Tray (sterilized using ethylene oxide) (China) •Benzalkonium Chloride Prep Pad (non-sterile) (USA) •10 mL Pre-filled Syringe with Sterile Water (sterilized using ethylene oxide) (China) •Vinyl Gloves (sterilized using ethylene oxide) (China) •Waterproof Drape (sterilized using ethylene oxide) (China) •Fenestrated Drape (sterilized using ethylene oxide) (China) •Lubricating Jelly (sterilized using ethylene oxide) (USA) •PVP Swabsticks (sterilized using ethylene oxide) (China)" FDA UDI
Identifiers
- Catalog Number
- AS882 FDA UDI
- Primary DI / UDI-DI
- 10704411019763 FDA UDI
- FDA Product Code
- FCM FDA UDI
- GMDN Term
- Urethral catheterization support kit, urinary drainage 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: Urethral catheterization support kit, urinary drainage
AMSure® Foley Catheter Tray by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Urethral catheterization support kit, urinary drainage.
- Urethral Catheterization Tray — Dynarex Corp. · Class II
- Bardia® Closed System Urinary Drainage Bag With Anti-Reflux Chamber — C. R. Bard, Inc. · Class II
- Bardia® Foley Catheter Insertion Tray — C. R. Bard, Inc. · Class II
- Bard® Add-A-Foley Tray with Bard EZ-LOK® Sampling Port — C. R. Bard, Inc. · Class II
- NEOMED* — Avanos Medical, Inc. · Class II
- Bard® Foley Catheterization Tray — C. R. Bard, Inc. · Class II
- Bard® Foley Catheterization Tray Uro-Prep™ Tray — C. R. Bard, Inc. · Class II
- ADDTO — ADDTO, 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 |
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Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (1)
- FDA UDI 8837fd93-9abe-4ad0-a39e-ef9605112bee 34 fields · synced May 30, 2026