HolterCare
Basic Information
- Brand Name
- HolterCare
- Primary DI
- 00856298006169
- Version / Model
- HolterCare
- Catalog Number
- 100087
- Company Name
- SCOTTCARE CORPORATION, THE
- Labeler DUNS
- 808204957
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 579ccc3e-ebc6-46cc-86ae-223337185128
Device Description
The ScottCare HolterCare Analysis System is intended for general hospital or clinical use by medical professionals whenever it is required to assess a patient’s long-term, continuous, ambulatory electrocardiogram (ECG). The long-term ECG is recorded on a digital flash memory Holter recorder. This product allows a trained physician, or other health care professional, to download and analyze the data from the recorder, review it, and produce printed reports. This will enable: The evaluation of arrhythmias and ischemic attacks. The reporting of PQRST intervals. Clinical and epidemiological research studies. The evaluation of a patient’s response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery). The evaluation of patients with Pacemakers. The need to record, review, edit, and archive the ambulatory ECG is most commonly encountered in the Cardiology areas of the hospital, or physician’s office, during cardiac assessment of a patient. This device is available for sale to, or on the order of, a licensed physician only and is not intended for any home-use applications.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DQK | Computer, Diagnostic, Programmable | Cardiovascular | 870.1425 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41651 | Electrocardiographic long-term ambulatory recording analyser application software | A dedicated application data program designed for use in, or together with, an electrocardiographic long-term ambulatory recording analyser so that this may function according to its intended purpose. This software program can be permanently installed, or exchanged as an upgrade. It may also be produced for installation in an off-the-shelf desktop or laptop computer. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856298006169 | GS1 |
Customer Contacts
- Phone
- 216-362-0550
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042463 | 000 |