CARESCAPE 1506-8600-000
GUDID 00840682102346
DATEX-OHMEDA INC
Neonatal/adult intensive-care ventilator| Primary Device ID | 00840682102346 |
| NIH Device Record Key | ba2f27df-5f57-418d-90a8-f0871ae2b562 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CARESCAPE |
| Version Model Number | R860 |
| Catalog Number | 1506-8600-000 |
| Company DUNS | 129501685 |
| Company Name | DATEX-OHMEDA INC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
Customer Support Contacts
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx | |
| Phone | +1(800)345-2700 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
| Storage Environment Temperature | Between -15 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 49.99 KiloPascal and 106.66 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682102346 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K142679
FDA Product Code
| CBK | VENTILATOR, CONTINUOUS, FACILITY USE |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-09-23 |
Devices Manufactured by DATEX-OHMEDA INC
| 00195278115171 - NOVII | 2024-06-11 NOVII+ POD |
| 00195278212313 - NOVII | 2024-06-11 NOVII+ INTERFACE |
| 00840682143677 - Giraffe In-Bed Scale | 2023-06-19 ASSY-LAU, GIRAFFE IN-BED SCALE, Finished good - Buy |
| 00840682143721 - Panda In-Bed Scale | 2023-06-19 ASSY-LAU, PANDA IN-BED SCALE, Finished good - Buy |
| 00840682145596 - Carestation 750 | 2023-04-12 CARESTATION 750 A1 |
| 00840682146425 - Carestation 750c | 2023-04-12 CARESTATION 750c A1 |
| 00840682143684 - IV POLE ASSY 12 IN | 2022-12-14 IV POLE 12 IN |
| 00840682143691 - ROTATING IV POLE | 2022-12-14 ROTATING IV POLE |
Trademark Results [CARESCAPE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CARESCAPE 77059764 3570349 Live/Registered |
General Electric Company 2006-12-08 |
 CARESCAPE 75619287 not registered Dead/Abandoned |
Reddy, Rama M. 1999-01-19 |
 CARESCAPE 75574654 2316008 Live/Registered |
Carescape, Inc. 1998-10-21 |
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