| Primary Device ID | 40862146000300 |
| NIH Device Record Key | fc62dd75-37c2-4f3a-a0ee-85d71f549c68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | WaterPAP PRO |
| Version Model Number | WP-7800 |
| Company DUNS | 109509435 |
| Company Name | AIRWAYS DEVELOPMENT COMPANY LLC |
| 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 | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00862146000319 [Primary] |
| GS1 | 30862146000303 [Package] Contains: 00862146000319 Package: Box [10 Units] In Commercial Distribution |
| GS1 | 40862146000300 [Package] Contains: 30862146000303 Package: Case [4 Units] In Commercial Distribution |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-05 |
| Device Publish Date | 2016-09-26 |
| 90862146000329 - WaterPAP Starter Kit | 2018-11-05 WaterPAP Starter Kit consists of 4 WaterPAP canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole clamp, Instructions for |
| 90862146000336 - WaterPAP PRO Starter Kit | 2018-11-05 WaterPAP PRO Starter Kit consists of 4 WaterPAP PRO Canisters, 4 10mm Corrugated tubes, 1 Metal Bracket, 1 Pole Clamp, Instructi |
| 20862146000306 - WaterPAP | 2018-11-05 Positive Airway pressure device |
| 40862146000300 - WaterPAP PRO | 2018-11-05 |
| 40862146000300 - WaterPAP PRO | 2018-11-05 |