Identity
- Trade Name
- Filac FDA UDI
- Generic Name
- Intermittent electronic patient thermometer FDA UDI
- Device Name
- Rectal Complete System with 4’ (1.2 m) Cord FDA UDI
- Model / Reference
- 504005 FDA UDI
- Description
- Rectal Complete System with 4’ (1.2 m) Cord FDA UDI
Identifiers
- Catalog Number
- 504005 FDA UDI
- Primary DI / UDI-DI
- 10192253006377 FDA UDI
- FDA Product Code
- FLL FDA UDI
- GMDN Term
- Intermittent electronic patient thermometer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2910 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 4 Feet FDA UDI
Category: Intermittent electronic patient thermometer
Filac by Cardinal Health 200, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent electronic patient thermometer.
- CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
- Amico Diagnostic Station — Amico Diagnostic Incorporated · Class II
- ESSEF — Hangzhou Hua'An Medical & Health Instruments Co., · Class II
- Rongfeng — Shen Zhen Rong Feng Technology Co., Ltd. · Class II
- iProvèn — Masena Invest B.V. · Class II
- Rite Aid — 180 INNOVATIONS LLC · Class II
- Family Wellness — Family Dollar Stores · Class II
- up&up — TARGET CORPORATION · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Cardinal Health 200, LLC
Sources (1)
- FDA UDI d56578ab-b4ab-4223-a04f-892f9f1626d8 36 fields · synced Jun 8, 2026