Primary Device ID | 07540184110124 |
NIH Device Record Key | f34ff046-c57c-4b3b-b9b8-edc6d3dae0d9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | OptoWire |
Version Model Number | Deux |
Catalog Number | F1012 |
Company DUNS | 253717946 |
Company Name | Opsens 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 | true |
Lot Batch | true |
Serial Number | false |
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 |
Length | 175 Centimeter |
Length | 175 Centimeter |
Length | 175 Centimeter |
Length | 175 Centimeter |
Length | 175 Centimeter |
Length | 175 Centimeter |
Length | 175 Centimeter |
Length | 175 Centimeter |
Length | 175 Centimeter |
Length | 175 Centimeter |
Length | 175 Centimeter |
Length | 175 Centimeter |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 0 Degrees Celsius and 54 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *Keep dry. Keep away from sunlight |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07540184110124 [Primary] |
GS1 | 07540184310128 [Package] Contains: 07540184510122 Package: shipping box [20 Units] In Commercial Distribution |
GS1 | 07540184510122 [Package] Package: carton box [5 Units] In Commercial Distribution |
DXO | Transducer, Pressure, Catheter Tip |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2020-01-14 |
Device Publish Date | 2016-09-24 |
00754018410121 | Pressure guidewire |
07540184110124 | Pressure guidewire |
07540184010325 | Pressure guidewire |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() OPTOWIRE 88721716 not registered Live/Pending |
OPSENS INC. 2019-12-10 |
![]() OPTOWIRE 86384221 4983992 Live/Registered |
OPSENS INC. 2014-09-03 |