Primary Device ID | 00860000221306 |
NIH Device Record Key | ad796bcb-7265-45c2-a0b0-a72e62706af6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SoftVue |
Version Model Number | Atlantic |
Catalog Number | 900-00035 |
Company DUNS | 963425017 |
Company Name | Delphinus Medical Technologies, 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 | true |
OTC Over-The-Counter | false |
Phone | 1 (844) 763-8883 |
service@delphinusmt.com | |
Phone | 1 (844) 763-8883 |
service@delphinusmt.com | |
Phone | 1 (844) 763-8883 |
service@delphinusmt.com | |
Phone | 1 (844) 763-8883 |
service@delphinusmt.com |
Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 5 Degrees Celsius and 43 Degrees Celsius |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00860000221306 [Primary] |
PAA | Automated Breast Ultrasound |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-15 |
Device Publish Date | 2022-12-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SOFTVUE 87043815 not registered Live/Pending |
Delphinus Medical Technologies, Inc. 2016-05-19 |
SOFTVUE 74514735 not registered Dead/Abandoned |
O.S.I. Corporation 1994-04-15 |