| Primary Device ID | 10850108006551 |
| NIH Device Record Key | 111701a8-8c41-4f4b-901c-1ea5edfa407d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RespVac™ |
| Version Model Number | RTG-03020 |
| Catalog Number | RTG-03020 |
| Company DUNS | 080216804 |
| Company Name | CUTTING EDGE HC BRANDS LLC |
| 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 | true |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 9999999999 |
| info@respiratorytg.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850108006554 [Primary] |
| GS1 | 10850108006551 [Package] Contains: 00850108006554 Package: Carton [50 Units] In Commercial Distribution |
| JOL | Catheter And Tip, Suction |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 6 |
| Public Version Date | 2020-05-11 |
| Device Publish Date | 2016-09-23 |
| 10850108006582 | RespVac Yankauer Suction Handle Flange Tip Vented Sterile |
| 10850108006575 | RespVac Yankauer Suction Handle Flange Tip Non-Vented Sterile |
| 10850108006568 | RespVac Yankauer Suction Handle Bulb Tip Vented Sterile |
| 10850108006551 | RespVac Yankauer Suction Handle Bulb Tip Non-Vented Sterile |
| 10850108006544 | RespVac Suction Connecting Tubing Kit Non-Sterile, 3/16" x 6' tube and 3/16" x 18" tube |
| 10850108006537 | RespVac Suction Connecting Tubing 3/16" X 18" Sterile |
| 10850108006520 | RespVac Suction Connecting Tubing 3/16" X 20' Sterile |
| 10850108006513 | RespVac Suction Connecting Tubing 3/16" X 12' Sterile |
| 10850108006506 | RespVac Suction Connecting Tubing 3/16" X 10' Sterile |
| 10850108006490 | RespVac Suction Connecting Tubing 3/16" X 6' Sterile |
| 10850108006483 | RespVac Suction Connecting Tubing 1/4" X 20' Sterile |
| 10850108006476 | RespVac Suction Connecting Tubing 1/4" X 12' Sterile |
| 10850108006469 | RespVac Suction Connecting Tubing 1/4" X 10' Sterile |
| 10850108006452 | RespVac Suction Connecting Tubing 1/4" X 6' Sterile |