Primary Device ID | 6944413808300 |
NIH Device Record Key | f9f58212-0a29-4c89-8cb2-5ee2b7fa49cb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PC ECG (Data Management Software) |
Version Model Number | SE-1515 |
Company DUNS | 529173163 |
Company Name | Edan Instruments, 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 | 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 | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06944413808294 [Primary] |
GS1 | 6944413808300 [Package] Contains: 06944413808294 Package: [10 Units] In Commercial Distribution |
DPS | Electrocardiograph |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-09 |
06944413820463 - Holter ECG and ABP System | 2023-12-08 |
06944413820470 - Holter ECG and ABP System | 2023-12-08 |
06944413820487 - Holter ECG and ABP System | 2023-12-08 |
06944413820494 - Holter ECG and ABP System | 2023-12-08 |
06944413820500 - Holter ECG and ABP System | 2023-12-08 |
06944413820562 - Electrocardiograph | 2023-12-08 |
06944413820616 - Electrocardiograph | 2023-12-08 |
06944413812680 - Ambulatory Blood Pressure Monitor | 2023-06-29 |