FDA.reportPublic FDA data

NA

Primary DI
00884838074651
Brand
NA
Company
Philips Medizin Systeme Böblingen GmbH
Model
989803100801
Catalog number
989803100801
Published
2016-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KLKMonitor, oxygen, cutaneous, for infant not under gas anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925910000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925910000HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULEHewlett-Packard Co.1993-07-29KLK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838074651PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838074651008848380746518848380746510884838074651

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, blood gas, transcutaneousA small unit dedicated to the measurement of blood gas tensions for the partial pressure of oxygen (pO2) and partial pressure of carbon dioxide (pCO2) transcutaneously (through the skin) in a patient's blood using a special sensor which is typically heated to improve local vascularity. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pO2/pCO2 signals measured and provided by this module.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(999)999-9999xx@xx.xx

Regulatory Flags#

DUNS number
314101143
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00884838073715NMT cableIntelliVue NMT Patient Cable9898031745812017-03-21
00884838085299Dual IBP AdapterDual IBP Adapter9898031997412026-10-21
20884838115389Nasal Alar SpO2 SensorNasal Alar SpO2 Sensor9898032053812026-10-16
20884838115396Nasal Alar SpO2 SensorNasal Alar SpO2 Sensor9898032053912026-10-16
00884838102866Telemetry Monitor 5500Telemetry Monitor 55008672342026-10-15
00884838096738Cardiac WorkstationCardiac Workstation 50008604502026-08-18
00884838096745Cardiac WorkstationCardiac Workstation 70008604512026-08-18
00884838119192Telemetry AccessoriesTelemetry Adapter Masimo SpO2-only9898032023912026-05-28
00884838119208Telemetry AccessoriesECG 5L Grabber, AAMI, Masimo SpO2 , Tele9898032024112026-05-28
00884838119215Telemetry AccessoriesECG 5L Grabber, IEC, Masimo SpO2 , Tele9898032024212026-05-28
00884838119222Telemetry AccessoriesTelemetry Adapter 6-Lead + Masimo SpO29898032042912026-05-28
00884838094826Cardiac WorkstationCardiac Workstation 50008604392025-01-24
00884838094833Cardiac WorkstationCardiac Workstation 70008604412025-01-24
00884838132320Patient Information Center iXPatient Information Center iX 4.88663892026-07-13
00884838132337Care AssistCare Assist iOS 4.89898032215312026-07-13
00884838132344Care AssistCare Assist Android 4.89898032215412026-07-13
00884838119017Telemetry AccessoriesECG 3 lead Grabber, AAMI + SpO2, Tele9898031718112026-05-28
00884838119024Telemetry AccessoriesECG 5 lead Snaps, AAMI, Tele9898031718212026-05-28
00884838119031Telemetry AccessoriesECG 5 lead Grabber, AAMI, Tele9898031718312026-05-28
00884838119048Telemetry AccessoriesECG 5 lead Snaps, AAMI + SpO2, Tele9898031718412026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSKLK2025-04-23
07640121880988103149 Calibration GasSenTec AGKLK2024-07-05
07640121880995103164 tCOM+SenTec AGKLK2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGKLK2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGKLK2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGKLK2024-07-05
07640121881039Non-Adhesive WrapSenTec AGKLK2023-07-21
07640121880964Patient Application Kit for mature intact skinSenTec AGKLK2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGKLK2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGKLK2021-09-26
17640121880961Patient Application Kit for mature intact skinSenTec AGKLK2021-09-26
07640121880889SDM Water Protection CoverSenTec AGKLK2021-08-25
07640121880902Isolation Transformer 100-120VSenTec AGKLK2021-05-05
07640121880933Membrane Changer (single-use) / single unitSenTec AGKLK2021-02-28
07640121880810Ear Clip easySenTec AGKLK2020-03-31
07640121880858Contact Gel 2mlSenTec AGKLK2019-03-08
17640121880862Contact GelSenTec AGKLK2019-03-05
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinSenTec AGKLK2019-01-29
07640121880797Multi-Site Attachment Ring for mature/intact skinSenTec AGKLK2019-01-29
00884838020849SO2 Optical ModulePhilips Medizin Systeme Böblingen GmbHKLK2018-12-18
07640121880315PSG-XSenTec AGKLK2018-11-12
07640121880612PSG Cable ASenTec AGKLK2018-11-12
07640121880629PSG Cable BSenTec AGKLK2018-11-12
07640121880636PSG Cable CSenTec AGKLK2018-11-12
07640121880643PSG Cable DSenTec AGKLK2018-11-12
07640121880650PSG Cable ESenTec AGKLK2018-11-12
07640121880667PSG Cable FSenTec AGKLK2018-11-12
07640121880674PSG Cable GSenTec AGKLK2018-11-12
07640121880681PSG Cable HSenTec AGKLK2018-11-12
07640121880698PSG Cable JSenTec AGKLK2018-11-12