FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Actiheart
DI: B329AH420
·
Model: AH4
·
CAMNTECH LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Actiheart
- Primary DI
- B329AH420
- Version / Model
- AH4
- Catalog Number
- 08-305
- Company Name
- CAMNTECH LIMITED
- Labeler DUNS
- 399114941
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2024-11-11
- Public Version Status
- Update
- Public Device Record Key
- 96e75109-6645-4035-ba26-c2651f598f6f
- Distribution End Date
- 2019-01-31
Device Description
Ambulatory ECG recorder with acclerometer - single channel
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| GWK | Conditioner, Signal, Physiological | Neurology | 882.1845 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38729 | Telemetric electrocardiographic ambulatory recorder | An electrically-powered, noninvasive device designed to be worn by a patient during daily activities for 24-hour recording of the electrocardiographic signals of the heart, for the diagnosis of cardiac disorders (e.g., arrhythmias). The recorded measurements can be wirelessly transmitted and analysed, typically to a remote computer with a dedicated software located at a medical facility. Otherwise known as a Holter monitor, the device typically incorporates display and controls, and may include surface electrodes, lead wires and accessories intended for attachment/removal (e.g., wipes, adhesive remover). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B329AH420 | HIBCC |
Customer Contacts
- Phone
- +1 830-755-8036
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K052489 | 000 |