FDA.reportPublic FDA data

NA

Primary DI
20840682103705
Brand
NA
Company
GE Healthcare Finland Oy
Model
Spirometry Tube, disposable, 2m/7ft
Published
2016-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

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
K051092000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051092000DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACCGE Healthcare2005-05-25CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20840682103705PackageGS15In Commercial Distribution
00840682103701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084068210370520840682103705
00840682103701008406821037018406821037010840682103701

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(800)558-5120xx@xx.xx

Regulatory Flags#

DUNS number
401966697
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682103022OxyTip SpO2OXY-FMR-002016-06-16
00840682103077OxyTip SpO2OXY-WMR-002016-06-16
00195278949752TruSignal SpO2 MM 3.0M159769772026-10-04
00195278949769TruSignal SpO2 MM 1.8M159560152026-10-04
00198953002186Carescape Dock F0157006022026-10-04
00840682106498Mobile CareWeb Viewer2016-06-21
00198953009567Carescape ONE259560312026-10-04
00840682102957EntropyGE Entropy sensor, M10386812016-08-15
00840682102971EntropyEasyFit sensor, M11744132016-08-15
00840682102964EntropyEntropy Cable, M1050784M10507842016-06-30
00840682103015NAPiCCO Injectate Sensor Cable2016-06-10
00840682103039NAPiCCO Continuous Cardiac Output Cable2016-06-16
00840682102841NAD-Lite Spirometry Kit 3m/10ft, 80043822016-08-15
00840682102858NAPedi-Lite Spirometry Kit 3m, M10326342016-08-15
00840682102865NAPedi-lite Spirometry Kit 2m, 80027182016-08-15
00840682102926NAMini D-fend Water Trap, 800217480021742016-08-12
00840682102896NACalibration Gas, 7555872016-06-10
00840682102902NACalibration Gas, 755571-HEL2016-06-10
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00195278697165PORTRAIT HSWXBHSWXB5700219-112024-04-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2024-12-19
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
B510PM2000XLPRO1ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBS2020-04-16