Midmark IQholter EX Digital Holter
The Midmark IQholter EX system combines a compact digital recorder with three powerful software applications. Includes the standard features of IQholter with expanded functionality for…
The Midmark IQholter EX system combines a compact digital recorder with three powerful software applications. Includes the standard features of IQholter with expanded functionality for A-Fib, QT/QTc and HRV analysis, template editing, Smart Page Scan and more. Kit includes: 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.
Who Else Makes It
Concentrated in Hebei (1), Shanghai (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Philips (China) Investment Co., Ltd. Philips Healthcare – Shanghai CDC | Shanghai | Shanghai | Specification developer | 6 |
Record
| Listed by | Midmark Corporation, United States |
|---|---|
| FDA product code | MLO |
| Device type | Electrocardiograph, Ambulatory, With Analysis Algorithm |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Special storage condition: Avoid extreme humidity and temperatures during use and storage, keep dry, keep away from direct sunlight.; Handling environment humidity 0 to 90 % RH; Handling environment temperature 0 to 40 °C; Storage environment humidity 0 to 90 % RH; Storage environment temperature 0 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4-000-0113 | 3.7″ x 2.6″ x 1.06″; Weight: 2.8 oz. (no battery or SD card) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HScribe | Mortara Instrument, Inc. | 55 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 41 |
| Millennia Software | Braemar Manufacturing, LLC | 18 |
| Patient Cable | Global Instrumentation, LLC | 13 |
| Modality Manager | Mortara Instrument, Inc. | 10 |
| Norav 1200 Series PC-ECG | Norav Medical Inc. | 6 |
| Matrix Holter System | Global Instrumentation, LLC | 5 |
| GI Holter System | Global Instrumentation, LLC | 5 |
| Cardiospy ECG Holter System | Labtech Kereskedelmi és Mérnöki Szolgáltató Korlátolt Felelősségű Társaság | 4 |
| WA Holter System | Global Instrumentation, LLC | 3 |
| Contec | Contec Medical Systems Co., Ltd. | 3 |
| Scribe | Mortara Instrument, Inc. | 2 |
Showing 12 of 33. All products under Electrocardiograph, Ambulatory, With Analysis Algorithm
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.