FDA.reportPublic FDA data

GE Healthcare Airway Gas Sampling Set

Primary DI
24251679601511
Brand
GE Healthcare Airway Gas Sampling Set
Company
BluePoint Medical GmbH & Co. KG
Model
Adult/Pediatric, 2m/7ft
Catalog number
8090121521
Device description
Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.
Published
2020-02-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24251679601511PrimaryGS10
EBPM8090121521SecondaryHIBCC0
04251679601517Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2425167960151124251679601511
04251679601517042516796015174251679601517

GMDN Terms#

Term, Definition table
TermDefinition
Gas-sampling/monitoring respiratory tubing, single-useA length of flexible noninvasive tube(s) primarily intended to be connected 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] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure495 Millimeter of Mercury795 Millimeter of Mercury
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius60 Degrees Celsius

Regulatory Flags#

DUNS number
507261522
Device count
20
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
24251679601528GE Healthcare Airway Gas Sampling SetInfant, 2m/7ft80901215222020-02-20
24251679601535GE Healthcare Airway Gas Sampling SetAdult/Pediatric, 3m/10ft80901215312020-02-20
24251679601542GE Healthcare Airway AdapterAdult/Pediatric30901210022020-02-20
14251679601781Reusable Temperature ProbeEsophageal/Rectal, Pediatric2107176-0322021-12-10
14251679601798Reusable Temperature ProbeEsophageal/Rectal, Adult2107176-0312021-12-10
14251679601804Reusable Temperature ProbeSkin, Adult2107176-0332021-12-10
04251679601517GE Healthcare Airway Gas Sampling Set Adult/Pediatric, 2m/7ft80901215212020-02-20
04251679601524GE Healthcare Airway Gas Sampling SetInfant, 2m/7ft80901215222020-02-20
04251679601531GE Healthcare Airway Gas Sampling SetAdult/Pediatric, 3m/10ft80901215312020-02-20
04251679601548GE Healthcare Airway AdapterAdult/Pediatric30901210022020-02-20

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Primary DI, Brand, Company table
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