Identity
- Trade Name
- Medichoice FDA UDI
- Generic Name
- Indwelling urethral catheterization kit, adult FDA UDI
- Device Name
- Tray Foley Insertion With 1000 Milliliter Outer Basin Tray 10 Cubic Centimeter Pre-Filled Syringe Of Sterile Water 1 Pair Vinyl Gloves 1 Waterproof Drape 1 Fenestrated Drape 1 3 Gram Pack Lubricating Jelly 3 Pvp Swab Sticks Sterile Not Made With Natural Rubber Latex MediChoice FDA UDI
- Model / Reference
- INTRAY80 FDA UDI
- Description
- Tray Foley Insertion With 1000 Milliliter Outer Basin Tray 10 Cubic Centimeter Pre-Filled Syringe Of Sterile Water 1 Pair Vinyl Gloves 1 Waterproof Drape 1 Fenestrated Drape 1 3 Gram Pack Lubricating Jelly 3 Pvp Swab Sticks Sterile Not Made With Natural Rubber Latex MediChoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632100420 FDA UDI
- FDA Product Code
- FCM FDA UDI
- GMDN Term
- Indwelling urethral catheterization kit, adult 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
Yes
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: Indwelling urethral catheterization kit, adult
Medichoice by Owens & Minor Distribution, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Dover — Cardinalhealth · Class II
- NURSE ASSIST — NURSE ASSIST, 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 |
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Manufacturer
- Manufacturer
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI 372a3fb3-ae47-460f-b80d-f3dd1ad72a3f 34 fields · synced May 30, 2026