Neumovent Graphnet Model 3179L1V

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Neumovent

Generic Name

Neonatal/adult intensive-care ventilator

Device Name

Neumovent Graphnet Neo

Neumovent Graphnet Ts

Model / Reference

GraphNet TS, GraphNet Neo, 1082A1, 1083A1V

Primary DI / UDI-DI

07798148080086, 07798148080109

Basic UDI-DI

B-07798148080109, B-07798148080086

510(k) Number

K101401 ↗

FDA Product Code

CBK

EMDN Code

Z1203010503, Z1203010504

GMDN Term

Neonatal/adult intensive-care ventilator

Device Class

Class IIb EUDAMED

Class II 510(k)GUDID

Regulation

21 CFR Part 868.5895

EU market of registration

Romania

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

GUDID distribution status

In Commercial Distribution

• Neumovent Graphnet

  Class II

  FDA 510(k) K111595 Active Cleared 27 Jan 2012

• What patient populations is the Neumovent Graphnet Model 3179L1V designed to support, and how does this differ from typical ventilators?

  The Neumovent Graphnet Model 3179L1V is explicitly designed for adult, pediatric, and neonatal patients requiring respiratory support, as indicated by its classification under the Anesthesiology advisory committee. This broader patient range distinguishes it from many ventilators, which may be limited to specific age groups or settings, ensuring versatility for critical care environments like ICUs.

• Is the Neumovent Graphnet Model 3179L1V intended for single-use or reusable applications, and what does this mean for maintenance?

  The device is supplied as a reusable medical instrument, meaning it is engineered for repeated use in facility settings. This requires adherence to manufacturer guidelines for cleaning, disinfection, and maintenance to ensure safety and functionality across multiple patients, unlike single-use devices that are discarded after one use.

• What regulatory pathways has the Neumovent Graphnet Model 3179L1V followed, and what does this imply for its use in clinical settings?

  The device has received FDA 510(k) clearance (K101401) under 21 CFR 868.5895 and MDD authorization, confirming it meets regulatory standards for facility-use ventilators. This implies it is approved for use in hospitals and critical care units, though it does not specify clinical indications—only that it is intended for controlled mechanical ventilation as described.

• How does the advisory committee classification (Anesthesiology) influence the device’s intended use in practice?

  The Anesthesiology advisory committee classification indicates the device’s primary role aligns with respiratory support during surgical procedures or intensive care, where precise ventilation control is critical. While it supports adult, pediatric, and neonatal patients, this classification suggests it is particularly optimized for scenarios requiring advanced ventilatory management, such as anesthesia or post-operative recovery.