Primary Device ID | 50190752178289 |
NIH Device Record Key | 5f7ca0cd-91db-475c-b93c-b4670fe9085b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | enFlow™ |
Version Model Number | 980200EU |
Catalog Number | 980200EU |
Company DUNS | 080456871 |
Company Name | VYAIRE MEDICAL, 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 | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | true |
OTC Over-The-Counter | false |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Storage Environment Atmospheric Pressure | Between 57 KiloPascal and 106 KiloPascal |
Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -30 Degrees Celsius and 70 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10190752178281 [Primary] |
GS1 | 20190752178288 [Package] Contains: 10190752178281 Package: Box [10 Units] In Commercial Distribution |
GS1 | 50190752178289 [Package] Contains: 20190752178288 Package: Case [30 Units] In Commercial Distribution |
LGZ | Warmer, thermal, infusion fluid |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-04-06 |
Device Publish Date | 2021-03-29 |
10190752188624 | Power Cord - US, Canada, Latin America |
50190752178289 | Disposable IV Fluid/Blood Warmer Cartridge Model 200 |
50190752147100 | Disposable IV Fluid/Blood Warmer Cartridge with IV Extension Model 202 |
10190752125803 | Controller Model 121 |
10190752125780 | IV Fluid/Blood Warmer Model 100 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENFLOW 78931674 3413404 Dead/Cancelled |
VITAL SIGNS, INC. 2006-07-18 |
ENFLOW 78922433 3407218 Live/Registered |
VITAL SIGNS, INC. 2006-07-05 |
ENFLOW 78922373 not registered Dead/Abandoned |
Enginivity LLC 2006-07-05 |
ENFLOW 78722539 3167989 Dead/Cancelled |
LINDE GAS LLC 2005-09-28 |
ENFLOW 77833560 3784492 Dead/Cancelled |
Goode, William H. 2009-09-23 |
ENFLOW 76467220 2897796 Dead/Cancelled |
LINDE AG 2002-11-14 |
ENFLOW 76461769 2870234 Dead/Cancelled |
LINDE AG 2002-10-25 |