Identity
- Trade Name
- AMSure® Foley Catheter Tray FDA UDI
- Generic Name
- Intermittent urethral catheterization kit FDA UDI
- Device Name
- AMSure® Foley Catheter Tray Silicone Coated Latex Foley Catheter - 5mL Balloon, Inflate with 10mL sterile water. Contents: 2000mL Drainage Bag, Silicone Coated Latex Foley Catheter, Wrap, Drape, Fenestrated Drape, Catheter Lubricating Jelly Sachet, Nitrile Golves (2), Forceps, Rayon Balls (5), Povidone-Iodine Solution, 10mL Syringe with Pre-filled Sterile Water, Specimen Container, Lid and Label FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSure® Foley Catheter Tray Silicone Coated Latex Foley Catheter - 5mL Balloon, Inflate with 10mL sterile water. Contents: 2000mL Drainage Bag, Silicone Coated Latex Foley Catheter, Wrap, Drape, Fenestrated Drape, Catheter Lubricating Jelly Sachet, Nitrile Golves (2), Forceps, Rayon Balls (5), Povidone-Iodine Solution, 10mL Syringe with Pre-filled Sterile Water, Specimen Container, Lid and Label FDA UDI
Identifiers
- Catalog Number
- AS89318 FDA UDI
- Primary DI / UDI-DI
- 10704411003847 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® Foley Catheter 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.
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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 bd0c6ade-40c7-4dfa-bd61-3bd08a062d0d 34 fields · synced May 30, 2026