FDA.reportPublic FDA data

GE Healthcare Airway Adapter

Primary DI
04251679601548
Brand
GE Healthcare Airway Adapter
Company
BluePoint Medical GmbH & Co. KG
Model
Adult/Pediatric
Catalog number
3090121002
Device description
Airway Gas Sampling Products are intended for continuous monitoring of expired and inspired respiratory gases.
Published
2020-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
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
24251679601542PrimaryGS10
EBPM3090121002SecondaryHIBCC0
04251679601548Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2425167960154224251679601542
04251679601548042516796015484251679601548

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.

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
507261522
Device count
25
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
24251679601511GE Healthcare Airway Gas Sampling Set Adult/Pediatric, 2m/7ft80901215212020-02-20
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

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