FDA.reportPublic FDA data

NA

Primary DI
00840682102902
Brand
NA
Company
GE Healthcare Finland Oy
Model
Calibration Gas, 755571-HEL
Device description
CALIBRATION GAS, 755571-HEL
Published
2016-06-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
BXKGAS, CALIBRATION (SPECIFIED CONCENTRATION)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BXKGas, Calibration (Specified Concentration)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682102902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682102902008406821029028406821029020840682102902

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia/respiratory gas flowmeter testerA device designed to determine the accuracy of an anaesthesia/respiratory gas flowmeter, or other respiratory equipment, by serving as a standard of gas flow measurement. Different types use different methods to measure the gas flow rate such as the use of a high-precision calibrated tube, or change in pressure caused by gas flow through an orifice. The device may be calibrated to indicate gas flow rate, e.g., when the outflow is open to the atmosphere or against a specific back pressure. It is intended to be used by a healthcare provider (i.e., clinical technician) in a clinical setting.

Regulatory Flags#

DUNS number
401966697
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00198953049181NAPiCCO Continuous Cardiac Output Cable2026-01-05
00195278697165PORTRAIT HSWXBHSWXB5700219-112024-04-30
00195278466662E-EEGXMJD1012022-07-01

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Primary DI, Brand, Company table
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00819601025950MasimoAirgas Therapeutics, LLCBXK2025-12-19
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