FDA.reportPublic FDA data

NA

Primary DI
20840682120658
Brand
NA
Company
GE Healthcare Finland Oy
Model
2097307-002
Published
2017-03-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
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
20840682120658PackageGS110In Commercial Distribution
00840682120654PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084068212065820840682120658
00840682120654008406821206548406821206540840682120654

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBQ2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CBQ2024-12-19
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
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
00840106905638PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905652PERMA PUREPERMA PURE LLCCBQ2024-11-06
00840106905669PERMA PUREPERMA PURE LLCCBQ2024-11-06