| Primary Device ID | 20190752135687 |
| NIH Device Record Key | fc4d0701-34e7-4e16-b9a7-734f0951b62e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | N/A |
| Version Model Number | M1091335VS |
| Company DUNS | 368457563 |
| Company Name | Vyaire Medical Oy |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com | |
| Phone | 1-833-327-3284 |
| customersupport@vyaire.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190752135680 [Primary] |
| GS1 | 20190752135687 [Package] Contains: 10190752135680 Package: [10 Units] In Commercial Distribution |
| BTL | Ventilator, Emergency, Powered (Resuscitator) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-11-27 |
| Device Publish Date | 2019-04-15 |
| 20190752135694 | T-Piece Neonatal Patient Circuit Kit, Disposable |
| 20190752135687 | T-Piece Neonatal Patient Circuit Kit, Disposable |
| 20190752135670 | T-Piece Neonatal Patient Circuit Kit, Disposable |
| 10190752138216 | ECG Leadwire Set, 6-Lead for ApexPro™ FH, Snap, AHA, 75 cm/ 29 in |
| 10190752138209 | ECG Leadwire Set, 5-Lead for ApexPro™ FH, Snap, AHA, 75 cm/ 29 in |
| 10190752138193 | ECG Leadwire Set, 3-Lead for ApexPro™ FH, Snap, AHA, 75 cm/ 29 in |
| 10190752138186 | ECG Leadwire Set, 6-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in |
| 10190752138179 | ECG Leadwire Set, 5-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in |
| 10190752138162 | ECG Leadwire Set, 3-Lead for ApexPro™ FH, Grabber, AHA, 75 cm/ 29 in |
| 20190752145334 | Leg Attachment Pad for Corometrics; Fetal Scalp Electrode Cable |
| 10190752180024 | ECG Leadwire, DIN, Radiolucent 5-lead, Grabber, AHA, 150 cm/59 in |
| 20190752143835 | Intratracheal Pressure Sensor |
| 10190752181410 | Compatibility ECG Care Cable, from 300-Series Leadwire Set to Multi-Link™, 3/5-Lead, AHA, 3 m/ |
| 50190752160437 | MRI Extension Tubing Set-Patient Breathing Circuit for iVent™ 201 |
| 50190752148633 | Patient Breathing Circuit for iVent™ 201, 1.8 m/6 ft., Disposable |
| 50190752148626 | Patient Breathing Circuit for iVent™ 201, 1.8 m/6 ft., Disposable |
| 10190752145320 | Patient Breathing Circuit for iVent™ 201, 1.8 m/6 ft, Disposable |
| 10190752145313 | Y-piece Flow Sensor for iVent™ 201, Disposable |
| 50190752145304 | Patient Breathing Circuit for iVent™ 201, 1.8 m/6 ft,Disposable |
| 10190752129351 | Patient Breathing Circuit for iVent™ 201, 4 m/ 13 ft, Disposable |
| 10190752125711 | Patient Breathing Circuit for iVent™ 201, 4 m/ 13 ft, Disposable |
| 10190752110441 | Compatibility ECG Care Cable, from 300-Series Leadwire Set to Multi-Link™, 3/5-Lead, AHA, 3 m/ |