Primary Device ID | 00812324000297 |
NIH Device Record Key | 2076d575-f258-46d1-a9a2-b84fb04d37f8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GEMS Mobile ECG |
Version Model Number | GM |
Catalog Number | GM |
Company DUNS | 251043907 |
Company Name | CardioComm Solutions, Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00812324000297 [Primary] |
DXH | Transmitters And Receivers, Electrocardiograph, Telephone |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-03-28 |
Device Publish Date | 2025-03-20 |
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