FDA.reportPublic FDA data

NA

Primary DI
00884838073579
Brand
NA
Company
Philips Medizin Systeme Böblingen GmbH
Model
989803145671
Catalog number
989803145671
Published
2016-11-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBSANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151681000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151681000IntelliVue Patient MonitorPhilips Medizin Systeme Boeblingen GmbH2015-07-17DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838073579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838073579008848380735798848380735790884838073579

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible tube(s) primarily intended to be used as an interface between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor]. It may be intended for pressure and flow monitoring and/or gas sampling, but does not include any components intended for delivery of medical gas to the patient; a microbial filter may be included. This is a single-use device.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00884838119055Telemetry AccessoriesECG 5 lead Grabber, AAMI + SpO2, Tele9898031718512026-05-28
00884838119062Telemetry AccessoriesECG 6 lead Grabber, AAMI, Tele9898031718612026-05-28
00884838119185Telemetry AccessoriesTelemetry Adapter 5-Lead + Masimo SpO29898032023812026-05-28
00884838119079Telemetry AccessoriesECG 6 lead Grabber, AAMI + SpO2, Tele9898031718712026-05-26
00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26

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Primary DI, Brand, Company table
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06944413815889Patient MonitorEdan Instruments, Inc.CBS2024-06-17
06944413815896Patient MonitorEdan Instruments, Inc.CBS2024-06-17
06944413815902Patient MonitorEdan Instruments, Inc.CBS2024-06-17
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCBS2024-05-13
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCBS2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCBS2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCBS2023-04-19
00195278524089NAGE Healthcare Finland OyCBS2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCBS2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCBS2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyCBS2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.CBS2022-04-12
00840682104135NAGE Healthcare Finland OyCBS2022-03-07
00840682104302NAGE Healthcare Finland OyCBS2022-03-07
00840682141291B1X5 Software UpgradeGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBS2020-11-18
00840682138574NAGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBS2020-11-16
00840682138581NAGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.CBS2020-11-16
B510PM2000M1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000TM1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000XL1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
B510PM2000XLPLUS1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16
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