Identity
- Trade Name
- Smart Caregiver FDA UDI
- Generic Name
- Radio-frequency identification reader FDA UDI
- Device Name
- Door Strip Monitor FDA UDI
- Model / Reference
- TL-4005 FDA UDI
- Description
- Door Strip Monitor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812293012604 FDA UDI
- FDA Product Code
- KMI FDA UDI
- GMDN Term
- Radio-frequency identification reader FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.2400 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radio-frequency identification reader
Smart Caregiver by Smart Caregiver Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radio-frequency identification reader.
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- ORLocate — STERIS CORPORATION · Class I
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- SCOPE ID TAG — Olympus Medical Systems 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 I | Pending data |
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Manufacturer
- Manufacturer
- Smart Caregiver Corporation
Sources (1)
- FDA UDI be4941b6-321a-42dc-97fc-7c10b7929d8e 33 fields · synced Jun 7, 2026