| Primary Device ID | 05713495000084 |
| NIH Device Record Key | 30303305-0891-4975-9f3f-2d55c0e2376b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Skytrofa Auto-Injector |
| Version Model Number | 1002247 |
| Company DUNS | 306047440 |
| Company Name | Phillips-Medisize A/S |
| 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 | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05713495000077 [Primary] |
| GS1 | 05713495000084 [Package] Contains: 05713495000077 Package: [10 Units] In Commercial Distribution |
| KZH | Introducer, Syringe Needle |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-11-01 |
| Device Publish Date | 2021-10-22 |
| 05713495001043 - VYAFUSER™ | 2024-11-21 The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV |
| 05713495000084 - Skytrofa Auto-Injector | 2021-11-01 |
| 05713495000084 - Skytrofa Auto-Injector | 2021-11-01 |
| 05713495000015 - BETACONNECT | 2021-10-15 |
| 05713495000039 - myBETAapp | 2021-10-15 |
| 05713495000046 - myBETAapp | 2021-10-15 |
| 05713495000053 - myBETAapp | 2021-10-15 |
| 05713495000060 - myBETAapp | 2021-10-15 |