VitaloROV
GUDID 05099169919105
9100 VITALOGRAPH VitaloROV (En)
VITALOGRAPH (IRELAND) LIMITED
Pulmonary function analysis system, adult| Primary Device ID | 05099169919105 |
| NIH Device Record Key | 09326999-976a-413c-b8f3-51c01aefaebd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VitaloROV |
| Version Model Number | 9100 |
| Company DUNS | 219683489 |
| Company Name | VITALOGRAPH (IRELAND) LIMITED |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05099169919105 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221030
FDA Product Code
| BTY | CALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION |
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 | 2024-08-08 |
| Device Publish Date | 2024-07-31 |
Devices Manufactured by VITALOGRAPH (IRELAND) LIMITED
| 05099169919105 - VitaloROV | 2024-08-089100 VITALOGRAPH VitaloROV (En) |
| 05099169919105 - VitaloROV | 2024-08-08 9100 VITALOGRAPH VitaloROV (En) |
| 15099169331898 - Mouthpiece | 2024-04-16 FRONT BITE-ON MOUTHPIECES |
| 05099169916104 - VitaloQUB | 2023-06-19 9160 VITALOGRAPH VitaloQUB - EN |
| 05099169830028 - IN2ITIVE | 2023-05-17 2120 In2itive |
| 05099169688001 - SPIROTRAC | 2023-04-04 7000 SPIROTRAC |
| 05099169673021 - COMPACT | 2023-02-20 6600 COMPACT |
| 05099169673038 - COMPACT | 2023-02-20 6600 COMPACT RMS |
| 05099169913103 - VitaloROV+ | 2022-11-22 9100 VITALOGRAPH VitaloROV+ (En) |
Trademark Results [VitaloROV]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VITALOROV 90657741 not registered Live/Pending |
Vitalograph (Ireland) Ltd. 2021-04-20 |
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