neoBLUE 001354
GUDID 00382830053198
The neoBLUE cozy™ Phototherapy System is a mobile phototherapy light that delivers a narrow band of high-intensity blue light via blue light emitting diodes (LEDs) to provide treatment for neonatal hyperbilirubinemia. The neoBLUE cozy light was designed for use within a patient enclosure, positioned under the baby
NATUS MEDICAL INCORPORATED
Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit Blanket/pad infant phototherapy unit| Primary Device ID | 00382830053198 |
| NIH Device Record Key | de5522ec-2616-420c-b5f0-696e87988c8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | neoBLUE |
| Version Model Number | Cozy |
| Catalog Number | 001354 |
| Company DUNS | 962519208 |
| Company Name | NATUS MEDICAL INCORPORATED |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com | |
| Phone | 1-800-303-0306 |
| Technical_service@natus.com |
Device Dimensions
| Width | 8.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
| Length | 17.5 Inch |
| Width | 8.5 Inch |
Operating and Storage Conditions
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -30 Degrees Celsius and 50 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00382830053198 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051869
FDA Product Code
| LBI | Unit, Neonatal Phototherapy |
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 | 2016-12-22 |
On-Brand Devices [neoBLUE]
| 00382830053686 | neoBLUE blanket Light Box |
| 00382830053198 | The neoBLUE cozy™ Phototherapy System is a mobile phototherapy light that delivers a narrow ba |
| 00382830015523 | neoBLUE blanket Small Disposable Mattress Cover |
| 00382830015516 | neoBLUE blanket Large Disposable Mattress Cover |
| 00382830015431 | neoBLUE blanket Small Mattress |
| 00382830015424 | neoBLUE blanket Large Mattress |
| 00382830015417 | neoBLUE blanket Small Pad Kit |
| 00382830015394 | neoBLUE blanket Large Pad Kit |
| 00382830005678 | Disposable mattress cover for the neoBLUE Cozy LED Phototherapy System |
Trademark Results [neoBLUE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEOBLUE 77256448 3466146 Live/Registered |
Natus Medical Incorporated 2007-08-15 |
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