| Primary Device ID | 00814079021657 |
| NIH Device Record Key | accbf23a-40ba-49ed-b17e-cfaaba183247 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OneMumPumpset D31 |
| Version Model Number | 63.00.125 |
| Catalog Number | 63.00.125 |
| Company DUNS | 481670396 |
| Company Name | Ardo medical 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 | 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 | true |
| Phone | +18444112736 |
| customer-service@ardo-usa.com | |
| Phone | +18444112736 |
| customer-service@ardo-usa.com |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814079021640 [Primary] |
| GS1 | 00814079021657 [Package] Contains: 00814079021640 Package: Box [30 Units] In Commercial Distribution |
| HGX | Pump, Breast, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-03-01 |
| 07640108054470 - Alyssa Hands-Free | 2024-01-30 Breast Pump, electric, with hands-free-pumpset |
| 07640108054494 - Hands-Free Double Pumpset | 2024-01-30 The Ardo Hands-Free Double Pumpset should be used in combination with the Ardo breastpumps and is intended for the expression an |
| 00814079022210 - Double Clinic Pumpset | 2023-09-14 The Ardo Pumpset should be used in combination with Ardo breastpumps and is intended to be used by lactating women to express an |
| 07640108051516 - Bellis | 2023-06-01 Breast Pumps, electric, with cooling bag |
| 07640108053961 - Alyssa to-go | 2023-06-01 Breast Pump, electric, with carry bag |
| 07640109059627 - Tulips Size S | 2023-05-31 Nipple Shields Size S |
| 00814079022111 - Tulips Size S | 2023-05-31 Nipple Shields Size S |
| 07640108053640 - Alyssa Double Plus | 2022-08-25 Breast Pump Double, electric |