Primary Device ID | 00817655022048 |
NIH Device Record Key | e5642206-ec21-48d0-a562-b25c5a115773 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | AM12 |
Version Model Number | 41000-032-54 |
Company DUNS | 062046149 |
Company Name | MORTARA INSTRUMENT, 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 | 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 | 888-667-8272 |
techsupport@mortara.com | |
Phone | 888-667-8272 |
techsupport@mortara.com |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00817655022048 [Primary] |
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 | 2020-06-29 |
Device Publish Date | 2017-09-19 |
00812345029680 | Wired Acquisition System cleared with the ELI 230 Electrocardiograph |
00812345029659 | Wired Acquisition System cleared with the ELI 230 Electrocardiograph |
00812345021776 | Wired Acquisition System cleared with the ELI 230 Electrocardiograph |
00812345021769 | Wired Acquisition System cleared with the ELI 230 Electrocardiograph |
00817655023137 | Wired Acquisition System cleared with the ELI 230 Electrocardiograph |
00817655022055 | Wired Acquisition System cleared with the ELI 230 Electrocardiograph |
00817655022048 | Wired Acquisition System cleared with the ELI 230 Electrocardiograph |