FDA.reportPublic FDA data

NA

Primary DI
00884838010055
Brand
NA
Company
Philips Medizin Systeme Böblingen GmbH
Model
989803100341
Catalog number
989803100341
Published
2017-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBQANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040917000PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026BPhilips Medizin Systeme Boeblingen GmbH2004-04-29CBQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00884838010055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00884838010055008848380100558848380100550884838010055

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
00884838120358Thermal Printer Kit, USBThermal Printer Kit, USB9898032050112026-06-04
00884838073715NMT cableIntelliVue NMT Patient Cable9898031745812017-03-21
00884838111462MR Patient Care Wireless ECG 3.0 Module (Networks 6-10)Wireless ECG 3.0 Module (Networks 6-10)9898031943412025-06-02
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
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
00884838119079Telemetry AccessoriesECG 6 lead Grabber, AAMI + SpO2, Tele9898031718712026-05-26
00884838119086Telemetry AccessoriesECG 3 lead Grabber, IEC + SpO2, Tele9898031719112026-05-26
00884838119093Telemetry AccessoriesECG 5 lead Grabber, IEC, Tele9898031719312026-05-26
00884838119109Telemetry AccessoriesECG 5 lead Grabber, IEC + SpO2, Tele9898031719512026-05-26
00884838119116Telemetry AccessoriesECG 6 lead Grabber, IEC, Tele9898031719612026-05-26
00884838119123Telemetry AccessoriesECG 6 lead Grabber, IEC + SpO2, Tele9898031719712026-05-26

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Primary DI, Brand, Company table
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90840106905075PERMA PUREPERMA PURE LLCCBQ2024-11-12
00840106906192PERMA PUREPERMA PURE LLCCBQ2024-11-12
00840106905157PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905164PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905171PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905195PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905201PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905218PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106905560PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106906086PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106906208PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106906215PERMA PUREPERMA PURE LLCCBQ2024-11-07
00840106906222PERMA PUREPERMA PURE LLCCBQ2024-11-07
00810020360141PERMA PUREPERMA PURE LLCCBQ2024-11-06
00810020360578PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905027PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905188PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905287PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905317PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905409PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905416PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905508PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905522PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905539PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905614PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905621PERMA PUREPERMA PURE LLCCBQ2024-11-06