Identity
- Trade Name
- HOLTER CONNECT FDA UDI
- Generic Name
- Physiological measuring device wireless data capture/transfer unit FDA UDI
- Device Name
- HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor. FDA UDI
- Model / Reference
- LA1252R FDA UDI
- Description
- HOLTER CONNECT Relay Application is a software that is installed on a compatible commercially available platform (mobile or tablet) that manages secured wireless communication between the Biosensor and the HOLTER CONNECT Secure Server for transferring acquired ECG data by the Biosensor. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B353LA1252R1 FDA UDI
- FDA Product Code
- DRG FDA UDIMWJ FDA UDI
- GMDN Term
- Physiological measuring device wireless data capture/transfer unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 FDA UDI870.2800 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Physiological measuring device wireless data capture/transfer unit
Holter Connect by LifeSignals, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- LifeSignals, Inc.
Sources (1)
- FDA UDI 61eeb35b-e9d7-4dfb-9351-b72269ab3640 34 fields · synced May 30, 2026