FDA UDI
In Commercial Distribution
🇺🇸 United States
Midmark IQholter® EP Digital Holter
DI: 00841709100611
·
Model: 4-000-0116
·
MIDMARK CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Midmark IQholter® EP Digital Holter
- Primary DI
- 00841709100611
- Version / Model
- 4-000-0116
- Catalog Number
- 4-000-0116
- Company Name
- MIDMARK CORPORATION
- Labeler DUNS
- 005036025
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 2430d24c-a903-468a-a173-73f749f1e25c
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36827 | Electrocardiographic long-term ambulatory recording analyser | An electronic device intended to be used for the analysis of long-term (often 24-hours) heart activity data, which has previously been registered by an electrocardiographic long-term ambulatory recorder (Holter), to which the patient was connected and carried upon his or her person. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00841709100611 | GS1 |
Customer Contacts
- Phone
- 1-800-624-8950
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 3.7" x 2.6" x 1.06"; Weight: 2.8 oz. (no battery or SD card) |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid extreme humidity and temperatures during use and storage, keep dry, keep away from direct sunlight.
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- 0 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 70 Degrees Celsius