Identity
- Trade Name
- Vista Solution® 2.0 10-day Evaluation Kit FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system FDA UDI
- Device Name
- Vista Solution® 2.0 10-day Evaluation Kit FDA UDI
- Model / Reference
- 9510-01 FDA UDI
- Description
- Vista Solution® 2.0 10-day Evaluation Kit FDA UDI
Identifiers
- Catalog Number
- 9510-01 FDA UDI
- Primary DI / UDI-DI
- 00850490007313 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Electrocardiography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Electrocardiography telemetric monitoring system
Vista Solution® 2.0 10-day Evaluation Kit by VitalConnect, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K192757 also covers:
K193343 also covers:
- Vista Solution 3 10-day Evaluation Kit — VitalConnect, Inc.
- Vista Solution® 10-day Evaluation Kit — VitalConnect, Inc.
- Vista Solution® 30-day Monitoring Kit — VitalConnect, Inc.
- VistaCenter — VitalConnect, Inc.
- VistaPhone — VitalConnect, Inc.
- VistaPhone — VitalConnect, Inc.
- VistaPhone — VitalConnect, Inc.
- VistaPoint Software User Interface — VitalConnect, Inc.
- VistaTablet — VitalConnect, Inc.
- VistaTablet — VitalConnect, Inc.
- VistaTablet™ 2.0 RELAY (W/O VCI Box) — VitalConnect, Inc.
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
- VitalConnect, Inc.
Sources (1)
- FDA UDI d61f4394-f823-4a2e-850a-237c4db206da 35 fields · synced Jun 8, 2026