Neumovent
GUDID 07798148080093
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.
Tecme Corporation
Neonatal/adult intensive-care ventilator| Primary Device ID | 07798148080093 |
| NIH Device Record Key | 45e824cc-5c16-47ea-bb6b-ebd41b9f0607 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neumovent |
| Version Model Number | GraphNet Advance |
| Company DUNS | 074574384 |
| Company Name | Tecme Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07798148080093 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111595
FDA Product Code
| CBK | Ventilator, Continuous, Facility Use |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2022-01-26 |
| Device Publish Date | 2015-10-29 |
On-Brand Devices [Neumovent]
| 07798148080109 | Intended to provide continuous ventilation to patients requiring respiratory support. The device |
| 07798148080093 | Intended to provide continuous ventilation to patient requiring ventilatory support. The devices |
| 07798148080086 | Intended to provide continuous ventilation to patients requiring respiratory support. The device |
Trademark Results [Neumovent]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEUMOVENT 85013338 4074744 Live/Registered |
Tecme S.A. 2010-04-14 |
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