FDA.reportPublic FDA data

HAMILTON-G5

Primary DI
07630002802208
Brand
HAMILTON-G5
Company
Hamilton Medical AG
Model
159002
Catalog number
159002
Device description
5900
Published
2024-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630002802208PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630002802208076300028022087630002802208

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal/adult intensive-care ventilatorA mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481492312
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630002800754HAMILTON-T11610051610052024-08-21
07630002800730HAMILTON-C21600021600022024-08-20
07630002802222HAMILTON-C31600061600062024-08-20
07630002801560HAMILTON-BC80222601612601612016-10-04
07630002806930Breathing circuit set, coaxial2602402022-12-08
07630002800303Breathing circuit set, coaxial2602072022-12-08
07630002800327Breathing circuit set, coaxial2602062022-12-08
07630002800860Flow sensor2816372022-12-08
07630002800877Flow sensor2820492022-12-08
07630002800891Flow sensor2820512022-12-08
07630002800921Breathing circuit set, coaxial2600872022-12-08
07630002800945Breathing circuit set, coaxial2600942022-12-08
07630002801133Expiratory valve set1602452022-12-08
07630002801362Flow sensor1555002022-12-08
07630002801935Breathing circuit set, coaxial2601442022-12-08
07630002801959Breathing circuit set, coaxial2601452022-12-08
07630002801980Expiratory valve set1611752022-12-08
07630002802529Flow sensor9501852022-12-08
07630002802734Expiratory valve set1611862022-12-08
07630002802840Flow sensor2601772022-12-08

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Primary DI, Brand, Company table
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