FDA.reportPublic FDA data

Compumedics Somte

Primary DI
09342451001498
Brand
Compumedics Somte
Company
COMPUMEDICS LIMITED
Model
7023-0006-01
Catalog number
7023-0006-01
Device description
SomtePSG THOR cable (Yellow)
Published
2016-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNRVentilatory Effort Recorder

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNRVentilatory Effort RecorderAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072201000COMPUMEDICS SOMTE PSG RECORDING SYSTEMCompumedics Limited2008-04-14MNR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09342451001498PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342451001498093424510014989342451001498

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity20 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61384207386support@compumedics.com.au
1-877-294-1346support@compumedicsusa.com

Regulatory Flags#

DUNS number
753750967
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09342451002433Compumedics CurryCURRY 98238-0044-012026-03-12
09342451002655Compumedics SomfitSomfit8037-0001-002026-03-12
09342451002662Compumedics SomfitSomfit Charger8037-0101-002026-03-12
09342451002747Compumedics FalconFalcon HST8036-0002-022026-03-12
09342451002754Compumedics FalconFalcon HST8036-0003-012026-03-12
09342451002785Compumedics FalconFalcon HST9036-0001-022026-03-12
09342451002822Compumedics SomfitSomfit9037-0003-002026-03-12
09342451002860Compumedics SomfitSomfit9037-0013-002026-03-12
09342451003416Compumedics Quik-GelQuik-Gel Electrolyte920000172026-03-12
09342451003423Compumedics Quik-GelQuik-Gel Electrolyte920000162026-03-12
09342451003430Compumedics Quik-GelQuik-Gel Electrolyte920000152026-03-12
09342451003447Compumedics Quik-GelQuik-Gel Electrolyte920000142026-03-12
09342451007063Compumedics Somfit DSomfit D9037-0022-002026-03-12
09342451004772Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 128 Ch La8035-0007-012026-03-03
09342451003904Compumedics Quik-CapQuik-Cap Hydrocell Array - SynAmps 2/RT 64 Ch Medi8035-0164-012026-03-02
09342451003980Compumedics Quik-CapQuik-Cap Neoprene Flexnet - Grael 128 Ch Medium8035-0154-012026-03-02
09342451003997Compumedics Quik-CapQuik-Cap Neoprene Flexnet - Grael 64 Ch Medium8035-0153-012026-03-02
09342451004000Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 256 Ch Me8035-0151-012026-03-02
09342451004017Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 128 Ch Me8035-0150-012026-03-02
09342451004024Compumedics Quik-CapQuik-Cap Neoprene Flexnet - SynAmps 2/RT 64 Ch Med8035-0149-012026-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08885021950013TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08885021950136TipTraQPRANAQ PTE. LTD.MNR2026-05-18
08720256698296Onera STS 2Onera B.V.MNR2026-05-15
08720256698302Onera STS 2Onera B.V.MNR2026-05-15
08720256698319Onera STS 2Onera B.V.MNR2026-05-15
08720256698326Onera STS 2Onera B.V.MNR2026-05-15
08720256698333Onera STS 2Onera B.V.MNR2026-05-15
08720256698340Onera STS 2Onera B.V.MNR2026-05-15
08720256698357Onera STS 2Onera B.V.MNR2026-05-15
08720256698364Onera STS 2Onera B.V.MNR2026-05-15
08720256698371Onera STS 2Onera B.V.MNR2026-05-15
08720256698463Onera STSOnera B.V.MNR2026-05-15
08720256698487Onera STSOnera B.V.MNR2026-05-15
08720256698494Onera STSOnera B.V.MNR2026-05-15
08720256698500Onera STSOnera B.V.MNR2026-05-15
08720256698517Onera STSOnera B.V.MNR2026-05-15
08720256698524Onera STSOnera B.V.MNR2026-05-15
08720256698531Onera STSOnera B.V.MNR2026-05-15
08885021950044TipTraQPRANAQ PTE. LTD.MNR2026-05-15
08885021950051TipTraQPRANAQ PTE. LTD.MNR2026-05-11
B566847001ZmachineGeneral SleepMNR2026-04-09
B566847002ZmachineGeneral SleepMNR2026-04-09
09342451002655Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002662Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002747Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002754Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002785Compumedics FalconCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002822Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451002860Compumedics SomfitCOMPUMEDICS LIMITEDMNR2026-03-12
09342451007063Compumedics Somfit DCOMPUMEDICS LIMITEDMNR2026-03-12