Lullaby
GUDID 00840682117401
DATEX-OHMEDA INC
Overhead infant phototherapy unit| Primary Device ID | 00840682117401 |
| NIH Device Record Key | a6282a2b-37cb-44f5-9281-275b3086c3b4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lullaby |
| Version Model Number | LED Phototherapy System |
| Company DUNS | 080887689 |
| Company Name | DATEX-OHMEDA 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 | 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 | |
| Phone | +1(800)345 2700 |
| xx@xx.xx |
Operating and Storage Conditions
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 0 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 107 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840682117401 [Primary] |
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 | 2018-04-19 |
| Device Publish Date | 2016-06-24 |
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 [Lullaby]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LULLABY 98132117 not registered Live/Pending |
Epic Saga Holdings LLC 2023-08-14 |
 LULLABY 97002933 not registered Live/Pending |
Smith Teamaker, LLC 2021-08-30 |
 LULLABY 90728688 not registered Live/Pending |
GOLD POINTER LIMITED 2021-05-22 |
 LULLABY 88584388 not registered Live/Pending |
Arise Medical LLC 2019-08-19 |
 LULLABY 88527619 not registered Live/Pending |
Chooze, Corp. 2019-07-22 |
 LULLABY 88527601 not registered Live/Pending |
Chooze, Corp. 2019-07-22 |
 LULLABY 88240580 5855618 Live/Registered |
YIWU YUXIN COMMODITY CO .,LTD 2018-12-24 |
 LULLABY 88166023 not registered Dead/Abandoned |
Dymedix Diagnostics, Inc. 2018-10-23 |
 LULLABY 87143156 not registered Dead/Abandoned |
Kenney Manufacturing Company 2016-08-18 |
 LULLABY 86930847 not registered Dead/Abandoned |
Lullaby Hospitality LLC 2016-03-07 |
 LULLABY 86000293 4558783 Live/Registered |
CPR IP ASSETS LLC 2013-07-02 |
 LULLABY 85662023 not registered Dead/Abandoned |
Endochoice, Inc. 2012-06-26 |
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