| Primary Device ID | 05060442521773 |
| NIH Device Record Key | fd474fd3-fdb8-413a-9a53-f4a82df33907 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Elvie Nipple Cushions |
| Version Model Number | ACCS-NCL02 |
| Company DUNS | 219386662 |
| Company Name | CHIARO TECHNOLOGY 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 | false |
| Lot Batch | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060442521773 [Primary] |
| PWA | Breast Pump Accessory, Milk Expression Aid, Via Positive Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-02 |
| Device Publish Date | 2023-05-25 |
| 05060442520561 - Elvie Pump Single AMZA | 2025-02-19 Elvie Pump - Single Electric Breast Pump - AMZA - Baked Breast pump, powered |
| 05060442522077 - Elvie Stride 2 | 2025-01-23 Powered breast pump - Single |
| 05060442522084 - Elvie Stride 2 Breast Shield | 2025-01-23 Elvie Stride 2 Breast Shield 2 x 28mm Breast Shield |
| 05060442522107 - Elvie Stride 2 Connect Kit (Single) | 2025-01-23 Elvie Stride 2 Connect Kit (Single). 1xCap Assembly, 1xLong PVC Tube with Puck Connector |
| 05060442522114 - Elvie Stride 2 Connect Kit (Double) | 2025-01-23 Elvie Stride 2 Connect Kit (Double) 2 Cap Assembly, 2xSilicone Tubes, 1xSplitter, 1xTube Splitter Bung, 1xPVC Tube with Puck Con |
| 05060442522121 - Elvie Stride 2 Cups | 2025-01-23 Elvie Stride 2 Cups 2 x Cups |
| 05060442522138 - Elvie Stride 2 Diaphragm | 2025-01-23 Elvie Stride 2 Diaphragm 2 x Diaphragm |
| 05060442522152 - Elvie Stride 2 Valves | 2025-01-23 Elvie Stride 2 Valves 3 x Valves |