Identity
- Trade Name
- Midmark IQholter® Digital Holter Recorder Kit FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording analyser FDA UDI
- Device Name
- Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available. Midmark IQHolter Recorder, Lead wire set, Secure Digital Card, Four Holter Prep Kits, and Reusable IQholter Recorder Pouch and Belt. FDA UDI
- Model / Reference
- 4-000-0119 FDA UDI
- Description
- Small and lightweight digital Holter recorder. Standard 24-hour recording with 48 and 72-hour recording capabilities available. Midmark IQHolter Recorder, Lead wire set, Secure Digital Card, Four Holter Prep Kits, and Reusable IQholter Recorder Pouch and Belt. FDA UDI
Identifiers
- Catalog Number
- 4-000-0119 FDA UDI
- Primary DI / UDI-DI
- 00841709100628 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® Digital Holter Recorder Kit 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 0ae7bf8b-1bab-4150-bf0c-928383333a10 37 fields · synced Jun 8, 2026