Identity
- Trade Name
- Prep Kit - Midmark IQholter, 5-lead FDA UDI
- Generic Name
- Electrocardiographic long-term ambulatory recording support kit FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 2-100-0080 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 2-100-0080 FDA UDI
- Primary DI / UDI-DI
- 00841709100697 FDA UDI
- FDA Product Code
- MLO FDA UDI
- GMDN Term
- Electrocardiographic long-term ambulatory recording support kit 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiographic long-term ambulatory recording support kit
Prep Kit - Midmark IQholter, 5-lead 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 e7e994a4-c5bf-43e9-8f41-37b1637c1bf1 36 fields · synced Jun 8, 2026