| Primary Device ID | 07612367016339 |
| NIH Device Record Key | 3c771051-7efe-4850-a31e-83b79761c7d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Holder with standard rail |
| Version Model Number | 079.0036 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1-877-735-1626 |
| info-healthcare@medela.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07612367016339 [Primary] |
| OMP | Negative Pressure Wound Therapy Powered Suction Pump |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-10-03 |
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| 07612367003698 - Overflow protection device | 2024-06-10 Overflow protection device |
| 07612367003735 - Reusable serial connector | 2024-06-10 Reusable serial connector |