Prep Kit – Midmark IQholter, 5-Lead
These kits are designed to provide the supplies you need for Holter testing. Kit contains: a diary, two AA batteries, razor, abrading pad, two alcohol wipes and five electrodes.
2manufacturers in China registered for this device type
1catalogue number
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 |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Avoid extreme humidity and temperatures during use and storage, keep dry, keep away from direct sunlight.; Handling environment temperature 10 to 32 °C; Storage environment temperature 10 to 32 °C |
| Packaging | Case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2-100-0080 | 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.