FDA UDI
In Commercial Distribution
🇺🇸 United States
Cardea SOLO
DI: 10857553006129
·
Model: C300/D300
·
CARDIAC INSIGHT, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Cardea SOLO
- Primary DI
- 10857553006129
- Version / Model
- C300/D300
- Catalog Number
- C300/D300
- Company Name
- CARDIAC INSIGHT, INC.
- Labeler DUNS
- 827419834
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-07-31
- Public Version
- 5
- Public Version Date
- 2019-11-08
- Public Version Status
- Update
- Public Device Record Key
- 9f6a63e5-7bc4-42b6-a8fc-ed193778648a
Device Description
Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300).
Device Characteristics
- Single Use
- Yes
- 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
- MR Unsafe
- 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 |
| DSH | Recorder, Magnetic Tape, Medical | Cardiovascular | 870.2800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35162 | 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 downloaded and analysed at a medical facility, typically using a computer with a dedicated software. 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 |
|---|---|---|---|---|---|---|
| Direct Marking | 00857553006122 | GS1 | ||||
| Primary | 10857553006129 | GS1 |
Customer Contacts
- Phone
- 2065962060
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162503 | 000 |