Neumovent

Primary DI
07798148080093
Brand
Neumovent
Company
Tecme Corporation
Model
GraphNet Advance
Device description
Intended to provide continuous ventilation to patient requiring ventilatory support. The devices are intended for patients from neonate/infant to adult. The devices are intended to be used in hospital and hospital type facilities and during hospital and Hospital -type transport provided that electrical power and compressed gas are supplied.
Published
2015-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111595000NEUMOVENT GRAPHNETTecme S.A.2012-01-27CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07798148080093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798148080093077981480800937798148080093

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

Contacts#

Phone, Email table
PhoneEmail
+17704099172technical.assistance@tecme-usa.com

Regulatory Flags#

DUNS number
074574384
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07798148080086NeumoventGraphNet TS2015-10-29
07798148080109NeumoventGraphNet Neo2015-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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