| Primary Device ID | 07612367050135 |
| NIH Device Record Key | 66deab96-bedd-4ee2-afaa-9731133cf37f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Invia Foam Dressing Kit |
| Version Model Number | 200.8908 |
| Company DUNS | 488293218 |
| Company Name | Medela AG |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1-877-735-1626 |
| info-healthcare@medela.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07612367050128 [Primary] |
| GS1 | 07612367050135 [Package] Contains: 07612367050128 Package: [3 Units] In Commercial Distribution |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-06-07 |
| 07612367050135 | Invia Foam Dressing Kit with Fitpad - X-Large Sales number: 087.6224 3 PCs |
| 07612367050111 | Invia Foam Dressing Kit with Fitpad - Large Sales number: 087.6223 3 PCs / 087.6227 15 pcs |
| 07612367050081 | Invia Foam Dressing Kit with Fitpad - Medium Sales number: 087.6222 3 PCs / 087.6226 15 pcs |
| 07612367050029 | Invia Foam Dressing Kit with Fitpad - Small Sales number: 087.6221 3 PCs / 087.6225 15 pcs |