SentrySuite V-770846
GUDID 04250892901053
SentrySuite Software
Vyaire Medical GmbH
Pulmonary function analysis system, adult| Primary Device ID | 04250892901053 |
| NIH Device Record Key | f78dffe0-aac0-4922-85d5-bacb5ea6b86b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SentrySuite |
| Version Model Number | 2.21 |
| Catalog Number | V-770846 |
| Company DUNS | 329769991 |
| Company Name | Vyaire Medical GmbH |
| 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 | false |
| Manufacturing Date | true |
| 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 | 04250892901053 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150810
FDA Product Code
| BZC | Calculator, Pulmonary Function Data |
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 | 2019-03-18 |
| Device Publish Date | 2017-11-17 |
Devices Manufactured by Vyaire Medical GmbH
| 14250892906833 - Vyaire | 2025-01-15 Extra Small Nasal Probes |
| 14250892906840 - Vyaire | 2025-01-15 Small Nasal Probes |
| 14250892906857 - Vyaire | 2025-01-15 Medium Nasal Probes |
| 14250892906864 - Vyaire | 2025-01-15 Large Nasal Probes |
| 04250892905945 - Vyaire | 2024-04-02 SentrySuite Software |
| 04250892905211 - MasterScreen | 2022-03-03 MasterScreen Body/Diff |
| 04250892905228 - MasterScreen | 2022-03-03 MasterScreen Body |
| 14250892906543 - Vyaire | 2021-11-24 Mouthpiece Adaptor |
Trademark Results [SentrySuite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENTRYSUITE 85166320 4161848 Live/Registered |
Vyaire Medical Capital LLC 2010-11-01 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.