FDA.reportPublic FDA data

Natus

Primary DI
00382830059763
Brand
Natus
Company
NATUS MEDICAL INCORPORATED
Model
025507
Device description
Monitor Adapter Cable, ICP, HP, MERLIN SERIES
Published
2024-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
GWMDevice, Monitoring, Intracranial Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWMDevice, Monitoring, Intracranial PressureNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121573000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121573000INTEGRA CAMINO ICP MONITORIntrgra Lifesciences Corporation2012-09-10GWM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830059763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830059763003828300597633828300597630382830059763

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081325959
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382830008365Bio-logicDisposable Snap Electrodes101600; 1016032016-12-30
00382830045247Echo-Screen III ProEchoScreen III Refurbished, TEOAE with barcode023480R2020-02-20
00382830045278Echo-Screen III ProEchoScreen III Refurbished, DPOAE with barcode023481R2020-02-20
00382830045292Echo-Screen III ProEchoScreen III Refurbished, ABR with barcode023482R2020-02-20
00382830045315Echo-Screen III ProEchoScreen III Refurbished, TEOAE & DPOAE with bar023483R2020-02-20
00382830045339Echo-Screen III ProEchoScreen III Refurbished, TEOAE & ABR with barco023484R2020-02-20
00382830045353Echo-Screen III ProEchoScreen III Refurbished, DPOAE & ABR with barco023485R2020-02-20
00382830000727NATUS MEDICAL2032002016-10-26
00382830000734Bio-logicOAE Foam Tip Pediatric203201, 294252016-12-30
00382830000741Bio-logicOAE Foam Tip Adult203202, 294272017-03-31
00382830000758Bio-logicOAE Tree Tip203208, 294212017-03-31
00382830000765Bio-logicOAE Tree Tip Preemie2032092017-03-31
00382830000772Bio-logicOAE Jumbo Tip2032102017-03-31
00382830000789Bio-logicOAE Foam Tip Pediatric203211, 294262016-12-30
00382830000796Bio-logicOAE Foam Tip Adult203212, 294282017-03-31
00382830000819Bio-logicOAE Tree Tip203218, 294222017-03-31
00382830000826Bio-logicOAE Tree Tip Preemie2032192017-03-31
00382830000833Bio-logicOAE 6mm Tip203333, 294232016-12-30
00382830000840Bio-logicOAE 6mm Tip203353, 294242016-12-30
00382830000871Natus Silver Disc Electrode Silicone1010012017-05-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701813000023Catheter Extension CableSOPHYSAGWM2026-10-27
03701813000030PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)SOPHYSAGWM2026-10-27
03701813000054Catheter Extension CableSOPHYSAGWM2026-10-27
03760409441510PRESSIO® 3 - PATIENT MONITOR EXTENSION CABLE - 3 PARAMETERS (ICP, ICT, MAP)SOPHYSAGWM2026-10-27
03760409441527PRESSIO®3 - PATIENT MONITOR CABLE PHILIPS, AGILENT, MINDRAY 12 pinsSOPHYSAGWM2026-10-27
03760409441534PRESSIO®3 - PATIENT MONITOR CABLE DRAEGER, SIEMENS 10 pinsSOPHYSAGWM2026-10-27
03760409441541PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB, MINDRAY 6 pinsSOPHYSAGWM2026-10-27
03760409441558PRESSIO®3 - PATIENT MONITOR CABLE GE DATEX OHMEDA 10 pinsSOPHYSAGWM2026-10-27
03760409441565PRESSIO®3 - PATIENT MONITOR CABLE GE SOLAR, MARQUETTE 11 pinsSOPHYSAGWM2026-10-27
03760409441572PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 5 pinsSOPHYSAGWM2026-10-27
03760409441589PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE PHILIPS, AGILENT 2 pinsSOPHYSAGWM2026-10-27
03760409441596PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DRAEGER, SIEMENS 7 pinsSOPHYSAGWM2026-10-27
03760409441602PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE SPACELAB 10 pinsSOPHYSAGWM2026-10-27
03760409441619PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE GE SOLAR, MARQUETTE, DATEX-OHMEDASOPHYSAGWM2026-10-27
03760409441626PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE DATEX-OHMEDA, NIHON KOHDEN, MINDRASOPHYSAGWM2026-10-27
03760409441633PRESSIO®3 - TEMPERATURE PATIENT MONITOR CABLE ARTIC SUNSOPHYSAGWM2026-10-27
03760409441640PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE PHILIPS Jack 3,5mmSOPHYSAGWM2026-10-27
03760409441657PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE DRAEGER INFINITYSOPHYSAGWM2026-10-27
03760409441671PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE without patient data moduleSOPHYSAGWM2026-10-27
03760409441688PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE GE CARESCAPE & GE with patient data moduSOPHYSAGWM2026-10-27
03760409441695PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY BENEVIEW T6 & UMEC SERIES 8, 10,SOPHYSAGWM2026-10-27
03760409441701PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY PASSPORT 8, 12 & EPM 10, 12SOPHYSAGWM2026-10-27
03760409441718PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE MINDRAY BENEVIEW N1, N12, N15, N17, N19,SOPHYSAGWM2026-10-27
03760409441725PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE NIHON KOHDEN LIFE SCOPE PT, LIFE SCOPE VSOPHYSAGWM2026-10-27
03760409441732PRESSIO®3 - ANALOG BLOOD PRESSURE CABLE NIHON KOHDEN LIFE SCOPE PT with YJ-920PSOPHYSAGWM2026-10-27
03760409441749PRESSIO®3 - MULTI-PARAMETER NEUROMONITOR ICP, ICT, CPPSOPHYSAGWM2026-10-27
03760409442074PRESSIO®3 - PATIENT MONITOR CABLE SPACELAB 10 pinsSOPHYSAGWM2026-10-27
03760409442081PRESSIO®3 - PATIENT MONITOR CABLE NIHON KOHDEN 14 pinsSOPHYSAGWM2026-10-27
03760409442098PRESSIO®3 - PATIENT MONITOR CABLE FUKUDA DENSHI 12 pinsSOPHYSAGWM2026-10-27
03760409442104PRESSIO®3 - PATIENT MONITOR CABLE FUKUDA DENSHI 11 pinsSOPHYSAGWM2026-10-27