FDA.reportPublic FDA data

NeoBeat Mini Sys Newborn Heart Rate Meter

Primary DI
07045432118339
Brand
NeoBeat Mini Sys Newborn Heart Rate Meter
Company
Laerdal Medical AS
Model
531-00001
Catalog number
531-00001
Device description
NeoBeat is a heart rate measurement device using dry-electrode technology, with integrated digital display.
Published
2024-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232111000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232111000NeoBeat, NeoBeat MiniLaerdal Medical AS2024-06-25MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07045432118339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07045432118339070454321183397045432118339

GMDN Terms#

Term, Definition table
TermDefinition
Wearable neonatal heart rate meterAn electrically-powered device designed to detect and display the heart rate of a neonate, typically within the first few hours after delivery. It consists of a display screen with sensor arms on each side, which are placed around the torso of the newborn. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Short-term storage temperature: -20 - 60 °C
Storage Environment Atmospheric Pressure62 KiloPascal106 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
730624095
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07045432119350The BAG™ Resuscitator - Newborn model847110401 2026-03-30
07045432119398The BAG™ Resuscitator - Pediatric model8472304012026-03-30
07045432119411The BAG™ Resuscitator - Adult model847340401 2026-03-30
07045432119503The BAG™ Resuscitator - Adult model847350401 2026-03-30
07045432119534The BAG™ Resuscitator - Pediatric model847220401 2026-03-30
07045432120462Laerdal Silicone Masks851500-12026-01-29
07045432120479Laerdal Silicone Masks851600-12026-01-29
07045432120486Laerdal Silicone Masks851700-1 2026-01-29
07045432120493Laerdal Silicone Masks860220-12026-01-29
07045432120509Laerdal Silicone Masks870220-12026-01-29
07045432116038The BAG Mask size 18470111 8470111 2026-01-14
07045432116045The BAG Mask size 2 847012184701212026-01-14
07045432116052The BAG Mask size 3 8470128470122026-01-14
07045432116069The BAG Mask size 484701412026-01-14
07045432116076The BAG Mask size 5847015184701512026-01-14
07045432116106The BAG PEEP Valve 2-10 cmH2O847021184702112026-01-14
07045432116113The BAG PEEP Valve 5-20 cmH2O8470211 8470211 2026-01-14
07045432116151The BAG Manometer8470401 8470401 2026-01-14
07045432115987The BAG Mask size 18470111 8470111 2026-01-14
07045432115994The BAG Mask size 2 847012184701212026-01-14

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Primary DI, Brand, Company table
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04255629200997NIBP Pressure cuff 27 - 35 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
04255629201000NIBP Pressure cuff 34 - 44 cmMIPM Mammendorfer Institut für Physik und Medizin GmbHMWI2026-06-24
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