Primary Device ID | 00857553006122 |
NIH Device Record Key | 9f6a63e5-7bc4-42b6-a8fc-ed193778648a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cardea SOLO |
Version Model Number | C300/D300 |
Catalog Number | C300/D300 |
Company DUNS | 827419834 |
Company Name | CARDIAC INSIGHT, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 2065962060 |
support@cardiacinsightinc.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00857553006122 [Direct Marking] |
GS1 | 10857553006129 [Primary] |
DQK | Computer, Diagnostic, Programmable |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-11-08 |
Device Publish Date | 2017-07-31 |
00857553006139 | Cardea SOLO PC Software - ECG analysis software (D300) |
00857553006122 | Cardea SOLO Analysis Package - ECG analysis software (D300) and data transfer cable (C300). |
10857553006112 | Cardea SOLO Wearable Sensor (M300) |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CARDEA SOLO 97628118 not registered Live/Pending |
CARDIAC INSIGHT, INC. 2022-10-11 |