Primary Device ID | 06944413824713 |
NIH Device Record Key | f555d7fb-0bd3-4211-a552-0ad4b21dc548 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RespArray quick start kit(AHA01) |
Version Model Number | 02.01.217622 |
Company DUNS | 529173163 |
Company Name | Edan Instruments, 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 | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
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 | 06944413824713 [Primary] |
GS1 | 16944413824710 [Package] Package: [4 Units] In Commercial Distribution |
DSA | Cable, Transducer And Electrode, Patient, (Including Connector) |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-10-19 |
Device Publish Date | 2022-10-11 |
06944413815889 - Patient Monitor | 2024-06-25 |
06944413815896 - Patient Monitor | 2024-06-25 |
06944413815902 - Patient Monitor | 2024-06-25 |
06944413813977 - ECG cable | 2024-06-06 |
06944413813984 - ECG cable | 2024-06-06 |
06944413813991 - ECG cable | 2024-06-06 |
06944413814004 - ECG cable | 2024-06-06 |
06944413814011 - ECG cable | 2024-06-06 |