Primary Device ID | 07613327504002 |
NIH Device Record Key | 502fb0af-8672-47c2-b1ab-f69e9fd13aa8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IsoAir |
Version Model Number | 2941 |
Catalog Number | 2941-000-001 |
Company DUNS | 078470558 |
Company Name | STRYKER CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
OTC Over-The-Counter | false |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 140 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07613327504002 [Primary] |
FNM | MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-09 |
Device Publish Date | 2020-09-01 |
07613327503999 | 2941 |
07613327504002 | 84 Inch System |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ISOAIR 85684233 4790917 Live/Registered |
Stryker Corporation 2012-07-23 |
ISOAIR 78762485 not registered Dead/Abandoned |
Air Innovations, Inc. 2005-11-29 |
ISOAIR 78193095 2910353 Live/Registered |
Particle Measuring Systems, Inc. 2002-12-10 |