| Primary Device ID | 08500501360013 |
| NIH Device Record Key | 481d028f-ee8a-4d9f-9d72-d3366987c2ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiWaze Cough Dual Lumen Circuit With Mouthpiece |
| Version Model Number | BC23387 |
| Catalog Number | BC23387 |
| Company DUNS | 033900786 |
| Company Name | Abmrc 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com | |
| Phone | +1-877-226-7201 |
| customer.service@abmrc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08500501360013 [Primary] |
| NHJ | Device, Positive Pressure Breathing, Intermittent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-09 |
| Device Publish Date | 2024-04-01 |
| 08500501360013 - BiWaze Cough Dual Lumen Circuit With Mouthpiece | 2024-04-09BiWaze Cough Dual Lumen Circuit With Mouthpiece |
| 08500501360013 - BiWaze Cough Dual Lumen Circuit With Mouthpiece | 2024-04-09 BiWaze Cough Dual Lumen Circuit With Mouthpiece |
| 08500501360020 - BiWaze Cough Dual Lumen Circuit With Trach Adapter | 2024-04-09 BiWaze Cough Dual Lumen Circuit With Trach Adapter |
| 08500501360037 - BiWaze Cough Dual Lumen Circuit With Face Mask - Child | 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Child |
| 08500501360044 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small | 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Small |
| 08500501360051 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium | 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Medium |
| 08500501360068 - BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large | 2024-04-09 BiWaze Cough Dual Lumen Circuit With Face Mask - Adult Large |
| 08500501360075 - BiWaze Clear Dual Lumen Circuit With Mouthpiece | 2023-08-02 BiWaze Clear Dual Lumen Circuit With Mouthpiece |
| 08500501360082 - BiWaze Clear Dual Lumen Circuit With Trach Adapter | 2023-08-02 BiWaze Clear Dual Lumen Circuit With Trach Adapter |