Identity
- Trade Name
- HOLTER CONNECT FDA UDI
- Generic Name
- Patient health record information system application software FDA UDI
- Device Name
- HOLTER CONNECT business logic is a software running on cloud platform that provides interface for technician to generate Holter report on ECG data of patient, provides interface for physician to access and e-sign the Holter Report generated by the ECG technician. FDA UDI
- Model / Reference
- LA1252C FDA UDI
- Description
- HOLTER CONNECT business logic is a software running on cloud platform that provides interface for technician to generate Holter report on ECG data of patient, provides interface for physician to access and e-sign the Holter Report generated by the ECG technician. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B353LA1252C1 FDA UDI
- FDA Product Code
- DRG FDA UDIMWJ FDA UDI
- GMDN Term
- Patient health record information system application software 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: Patient health record information system application software
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 2d252361-63f5-4593-bee2-c064e496dd2b 34 fields · synced Jun 8, 2026