Identity
- Trade Name
- RescueNet 12-Lead FDA UDI
- Generic Name
- Electrocardiography telemetric monitoring system FDA UDI
- Device Name
- Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads to aid in rapid patient treatment for acute STEMI. FDA UDI
- Model / Reference
- 8700-010001-01 FDA UDI
- Description
- Stand alone software used by EMS and Hospitals to collect, distribute, and view 12-Leads to aid in rapid patient treatment for acute STEMI. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847946021870 FDA UDI
- 510(k) Number
- K121865 FDA UDI
- FDA Product Code
- MSX FDA UDI
- GMDN Term
- Electrocardiography telemetric monitoring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 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
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: Electrocardiography telemetric monitoring system
RescueNet 12-Lead by Zoll Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K121865 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zoll Medical Corporation
Sources (1)
- FDA UDI 4e4ddef6-37a7-4538-b6b2-8a688c4e7fc5 34 fields · synced Jun 8, 2026