Identity
- Trade Name
- CALLCORD,8FT,GRAY,8 PIN MODULAR FDA UDI
- Generic Name
- Fixed call button FDA UDI
- Device Name
- CALLCORD,8FT,GRAY,8 PIN MODULAR FDA UDI
- Model / Reference
- CC96-080 FDA UDI
- Description
- CALLCORD,8FT,GRAY,8 PIN MODULAR FDA UDI
Identifiers
- Catalog Number
- 5835 FDA UDI
- Primary DI / UDI-DI
- 00840828126960 FDA UDI
- FDA Product Code
- ILQ FDA UDI
- GMDN Term
- Fixed call button FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.3710 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Fixed call button
The CALLCORD, an 8ft gray 8-pin modular device, is a fixed call button designed to provide hands-free assistance with medical needs. It features a wireless radio-frequency transmitter that sends a notification to a nurse call or home alert system when manually activated, allowing caregivers and medical professionals to respond quickly in emergency situations. The device is intended for use in the home and healthcare facility.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Curbell Medical Products, Inc.
Sources (1)
- FDA UDI 149d7dee-fb98-4ccc-9b15-eb25dc21b9d8 35 fields · synced Jul 30, 2026