Identity
- Trade Name
- Midmark IQholter® EP Digital Holter FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
- Device Name
- The Midmark IQholter® EP system combines a compact digital recorder with three powerful software applications. Includes all the features of IQholter® EX plus Pacemaker detection of single and dual-chamber paced beats for non-captures and sensing failures.situations in fast-paced offices. Kit includes: Midmark IQholter EP with Pacemaker Detection, Midmark IQholter Recorder (includes Lead Wire Set, Secure Digital Card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key, USB Version, and Holter Prep Kits. FDA UDI
- Model / Reference
- 4-000-0116 FDA UDI
- Description
- The Midmark IQholter® EP system combines a compact digital recorder with three powerful software applications. Includes all the features of IQholter® EX plus Pacemaker detection of single and dual-chamber paced beats for non-captures and sensing failures.situations in fast-paced offices. Kit includes: Midmark IQholter EP with Pacemaker Detection, Midmark IQholter Recorder (includes Lead Wire Set, Secure Digital Card), Reusable IQholter Recorder Pouch and Belt, Secure Digital Card Reader, Software Security Key, USB Version, and Holter Prep Kits. FDA UDI
Identifiers
- Catalog Number
- 4-000-0116 FDA UDI
- Primary DI / UDI-DI
- 00841709100611 FDA UDI
- FDA Product Code
- MLO FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2800 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
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrocardiographic long-term ambulatory recording analyser
Midmark IQholter® EP Digital Holter by Midmark Corporation — 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
- Midmark Corporation
Sources (1)
- FDA UDI 2430d24c-a903-468a-a173-73f749f1e25c 37 fields · synced Jun 8, 2026