Babyroo TN300 Infant Radiant Warmer

GUDID 04049098099042

DRAEGER MEDICAL SYSTEMS, INC.

Infant warmer
Primary Device ID04049098099042
NIH Device Record Keya8453ee7-30fb-49f4-8ed7-289c85f25cac
Commercial Distribution StatusIn Commercial Distribution
Brand NameBabyroo TN300 Infant Radiant Warmer
Version Model NumberMU20300
Company DUNS788289952
Company NameDRAEGER MEDICAL SYSTEMS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com
Phone+18004372437
Emailinfo@draeger.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104049098099042 [Primary]

FDA Product Code

FMTWarmer, Infant Radiant

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

Devices Manufactured by DRAEGER MEDICAL SYSTEMS, INC.

04049098099042 - Babyroo TN300 Infant Radiant Warmer2023-06-16
04049098099042 - Babyroo TN300 Infant Radiant Warmer2023-06-16
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04049098002066 - Infinity M300 Masimo WPA2 2020-02-06
04049098002172 - Omega-S Solution2020-02-06
04049098003858 - Infinity Vista XL Monitor2020-02-06
04049098003865 - INFINITY GAMMMA XL2020-02-06
04049098004022 - Vista Monitor2020-02-06
04049098004039 - Infinity Kappa Monitor2020-02-06

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