RediTube™ 8055RTC
GUDID 20190752152370
Tracheal Tube Oral/Nasal with Pre-loaded Stylet
VYAIRE MEDICAL, INC.
Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use Basic endotracheal tube, single-use| Primary Device ID | 20190752152370 |
| NIH Device Record Key | 5e941a6f-36c5-4bae-9c32-be5b62dcc42d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RediTube™ |
| Version Model Number | 8055RTC |
| Catalog Number | 8055RTC |
| Company DUNS | 080456871 |
| Company Name | VYAIRE MEDICAL, INC. |
| 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 |
Customer Support Contacts
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com | |
| Phone | +1(833)327-3284 |
| customersupport@vyaire.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190752152373 [Primary] |
| GS1 | 20190752152370 [Package] Contains: 50190752152371 Package: Box [40 Units] In Commercial Distribution |
| GS1 | 50190752152371 [Package] Contains: 10190752152373 Package: Case [160 Units] In Commercial Distribution |
| GS1 | 70190752152375 [Package] Package: Pack [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K042683
FDA Product Code
| BTR | Tube, tracheal (w/wo connector) |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-12 |
| Device Publish Date | 2021-04-02 |
On-Brand Devices [RediTube™]
| 50190752152395 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 50190752152388 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 20190752152370 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 20190752152356 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 70190752148767 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 20190752148755 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 50190752148749 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 70190752148736 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 50190752148725 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
Trademark Results [RediTube]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REDITUBE 75332234 2186986 Dead/Cancelled |
High Standard Products Corporation 1997-07-29 |
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