Avea 24-773170-102
GUDID 10190752167629
RESPITRACE Q.D.C.
VYAIRE MEDICAL, INC.
Home-use sleep apnoea recording system| Primary Device ID | 10190752167629 |
| NIH Device Record Key | bc367387-6cbf-49f7-9368-c31e2073da01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Avea |
| Version Model Number | 24-773170-102 |
| Catalog Number | 24-773170-102 |
| Company DUNS | 080456871 |
| Company Name | VYAIRE MEDICAL, INC. |
| 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 | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190752167629 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K012085
FDA Product Code
| OLV | Standard polysomnograph with electroencephalograph |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-22 |
| Device Publish Date | 2021-03-12 |
On-Brand Devices [Avea]
| 10190752156227 | AVEA Ventilator Espohageal Pressure Monitoring Tube Set, 6 FR Adult |
| 10190752167629 | RESPITRACE Q.D.C. |
| 10190752163300 | GAS & HOSE KIT TABLE VMAX 22 |
| 10190752162549 | REGULATOR O2 0-80 PSIG CGA 870 |
| 10190752167117 | AVEA, COMPREHENSIVE GENERIC |
| 10190752159075 | KIT, AVEA UPGRADE GDE & SOFTWARE |
| 10846446011913 | BATTERY, 2 PACK, AVEA |
| 10190752177048 | FLOW SENSOR,INSPIRATORY ASSEMBLY |
| 10190752174801 | BATTERY ASSEMBLY, 24V, 4.5AH, NIMH, AVEA |
| 10190752157767 | AVEA Ventilator |
| 10190752164055 | SPECTRA MAX PRESSURE OPTN CRYP |
| 10190752186439 | AVEA Ventilator |
| 20190752156231 | AVEA Ventilator Nasogastric Pressure Monitoring Tub Set, 7 FR Pediatric |
| 10190752186248 | AVEA II Ventilator - Avea Refresh |
| 10190752185784 | AVEA STD,W/CMP,ENG LNG,LO V,DISS,K |
| 10190752185685 | AVEA STD,N/CMP,ENG LNG,LO V,DISS,K |
| 10190752199835 | AVEA Ventilator Nasogastric Pressure Monitoring Tub Set, 7 FR Pediatric |
| 10190752199828 | AVEA Ventilator Esophageal Pressure Monitoring Tube Set, 6 FR Pediatric |
Trademark Results [Avea]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AVEA 88789556 not registered Live/Pending |
Avea Pools, LLC 2020-02-07 |
 AVEA 87875769 not registered Live/Pending |
Avea Pools, LLC 2018-04-13 |
 AVEA 86908412 5076829 Live/Registered |
AVEA AIR LIMITED 2016-02-16 |
 AVEA 86467834 4891504 Live/Registered |
EVE SYSTEMS GMBH 2014-12-01 |
 AVEA 79342994 not registered Live/Pending |
AVEA LIFE AG 2022-04-12 |
 AVEA 79330677 not registered Live/Pending |
AVEA LIFE AG 2021-10-15 |
 AVEA 79190649 5126557 Live/Registered |
Lee, Jung Hwa 2016-04-06 |
 AVEA 79122138 4356047 Live/Registered |
Avea Iletisim Hizmetleri Anonim Sirketi 2012-08-24 |
 AVEA 78569339 3169812 Dead/Cancelled |
Nutramedix, LLC 2005-02-17 |
 AVEA 78182354 2915141 Dead/Cancelled |
Taylor Management Ltd 2002-11-06 |
 AVEA 78182316 2895186 Dead/Cancelled |
Taylor Management Ltd 2002-11-06 |
 AVEA 76266510 2867175 Live/Registered |
VYAIRE MEDICAL CAPITAL LLC 2001-06-04 |
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