Neumovent

Primary DI
07798148080109
Brand
Neumovent
Company
Tecme Corporation
Model
GraphNet Neo
Device description
Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for neonate/infant patients.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
07798148080109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798148080109077981480801097798148080109

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
07798148080093NeumoventGraphNet Advance2015-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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