Identity
- Trade Name
- Fall Guardian FDA UDI
- Generic Name
- Bed/chair occupant movement pressure/vibration sensor FDA UDI
- Device Name
- Fall Guardian Wireless Economy Monitor with bed pad and pager case FDA UDI
- Model / Reference
- FG3B90R-SYS/CS FDA UDI
- Description
- Fall Guardian Wireless Economy Monitor with bed pad and pager case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812293015384 FDA UDI
- FDA Product Code
- KMI FDA UDI
- GMDN Term
- Bed/chair occupant movement pressure/vibration sensor 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: Bed/chair occupant movement pressure/vibration sensor
Fall Guardian by Smart Caregiver Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bed/chair occupant movement pressure/vibration sensor.
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- Parasol Wireless Patient Fall Prevention System — PARASOL MEDICAL · Class I
- UN MATT PAD-UNI-CONNECT-18MO-10X30-92" — CURBELL MEDICAL PRODUCTS, INC. · Class I
- Dynarex Protech 45-Day Chair Sensor Pad, 10" x 15" — Dynarex Corp. · Class I
- Parasol Patient Fall Prevention System — PARASOL MEDICAL · Class I
- BED PAD, FALL FIGHTER, 1/4 RECPT — Crest Healthcare Supply · Class I
- FALL FIGHTER, CHAIR PAD, 1/4 — Crest Healthcare Supply · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Smart Caregiver Corporation
Sources (1)
- FDA UDI d5bd0bf5-6327-44fa-9dcb-fbbf4164eec2 33 fields · synced May 30, 2026