| Primary Device ID | 00810104130998 |
| NIH Device Record Key | c6516233-ee0d-4fdb-a6f2-19d66178684c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Wave, Single, Tubing Set, Retail |
| Version Model Number | RSTS15 |
| Company DUNS | 050917861 |
| Company Name | WILLOW INNOVATIONS, INC. |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810104130998 [Primary] |
| HGY | Pump, Breast, Non-Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-31 |
| Device Publish Date | 2025-07-23 |
| 00810104130936 - Wave Single Manual Pump Kit | 2025-07-31 |
| 00810104130943 - Willow Sync, Pump Kit | 2025-07-31 |
| 00810104130950 - Wave, Container 5oz, Replacement | 2025-07-31 |
| 00810104130967 - Wave, Gasket, 2 pack, Retail | 2025-07-31 |
| 00810104130974 - Wave, Flapper Valves, 4 pack, Retail | 2025-07-31 |
| 00810104130981 - Wave, Flange 24mm, Replacement | 2025-07-31 |
| 00810104130998 - Wave, Single, Tubing Set, Retail | 2025-07-31 |
| 00810104130998 - Wave, Single, Tubing Set, Retail | 2025-07-31 |
| 00810104131001 - Wave, Handle, Replacement | 2025-07-31 |