NeoBeat Mini Sys Newborn Heart Rate Meter 531-00001

GUDID 07045432118339

NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.

Laerdal Medical AS

Wearable neonatal heart rate meter
Primary Device ID07045432118339
NIH Device Record Keyda5104f6-f969-4c86-aa7f-8e3c16310c47
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoBeat Mini Sys Newborn Heart Rate Meter
Version Model Number531-00001
Catalog Number531-00001
Company DUNS730624095
Company NameLaerdal Medical AS
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

Operating and Storage Conditions

Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short-term storage temperature: -20 - 60 °C
Storage Environment Atmospheric PressureBetween 62 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short-term storage temperature: -20 - 60 °C
Storage Environment Atmospheric PressureBetween 62 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short-term storage temperature: -20 - 60 °C
Storage Environment Atmospheric PressureBetween 62 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short-term storage temperature: -20 - 60 °C
Storage Environment Atmospheric PressureBetween 62 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Short-term storage temperature: -20 - 60 °C
Storage Environment Atmospheric PressureBetween 62 KiloPascal and 106 KiloPascal
Handling Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107045432118339 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-23
Device Publish Date2024-12-13

Devices Manufactured by Laerdal Medical AS

07045432112511 - NeoBeat Sys Newborn Heart Rate Meter2024-12-23 NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
07045432118308 - NeoBeat Mini Newborn Heart Rate Meter2024-12-23 NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
07045432118322 - NeoBeat Newborn Heart Rate Meter2024-12-23 NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
07045432118339 - NeoBeat Mini Sys Newborn Heart Rate Meter2024-12-23NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
07045432118339 - NeoBeat Mini Sys Newborn Heart Rate Meter2024-12-23 NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
07045432101676 - McKesson CPR Mask, Barrier Dev. 735082023-02-14 The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, child or infant.
07045432112269 - Newborn Mask - Size 0 Qty 1 - Snap Design2022-12-08 Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615601, LGH-84615601
07045432112399 - Newborn Mask - Size 1 Qty 1 - Snap Design (US)2022-12-08 Newborn Masks are intended for face mask ventilation of newborns and infants. Ref 10-pack cases Models: 84615701, LGH-84615701
07045432101690 - McKesson CPR Mask, Barrier Dev. w/O2 735092021-12-14 The McKesson CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult.

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