| Primary Device ID | 05099169209299 |
| NIH Device Record Key | e65bd576-11a8-4e32-b987-4326fbb91746 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Safe-T-Way |
| Version Model Number | 2024 |
| Company DUNS | 219683489 |
| Company Name | VITALOGRAPH (IRELAND) LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05099169209299 [Package] Contains: 15099169209296 Package: [200 Units] In Commercial Distribution |
| GS1 | 15099169209296 [Primary] |
| GS1 | 55099169209294 [Package] Package: [16 Units] In Commercial Distribution |
| BZG | SPIROMETER, DIAGNOSTIC |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2018-05-15 |
| 05099169297982 | STRUT WATERS PO |
| 05099169297975 | MNT BKT MWATERS POT |
| 55099169297710 | 2024 SafeTway MOUTHPIECES INSPIRATORY AIM |
| 55099169209898 | Oval MOUTHPIECES |
| 05099169209800 | 2024 SafeTway MOUTHPIECES MINI |
| 05099169209299 | ECO SafeTway MOUTHPIECES |
| 55099169209249 | 2024 SAFETWAY MOUTHPIECE |
| 55099169209225 | 2024 SAFETWAY MOUTHPIECE |
| 55099169209201 | 2024 SAFETWAY MOUTHPIECES |
| 55099169203926 | FRONT BITE-ON MOUTHPIECES |
| 55099169202462 | 2024 SafeTway MOUTHPIECES 200 IN BAGS OF 25 |
| 05099169202429 | 20242 Safe-T-Way Mouthpiece |
| 05099169202023 | MINI MOUTHPIECES |
| 05099169202016 | STANDARD DISPOSABLE MOUTHPIECES |
| 05099169297722 | SPACER TRAINER |