RediTube™ 8030RTUC
GUDID 70190752152320
Tracheal Tube Oral/Nasal with Pre-loaded Stylet
Sunmed Group Holdings, LLC
Basic endotracheal tube, single-use| Primary Device ID | 70190752152320 |
| NIH Device Record Key | 8dfaddee-d39a-4717-8b36-c5fcf318b75a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RediTube™ |
| Version Model Number | 8030RTUC |
| Catalog Number | 8030RTUC |
| Company DUNS | 119058668 |
| Company Name | Sunmed Group Holdings, 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 |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Storage Environment Temperature | Between 0 and 49 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Keep Dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10190752152328 [Primary] |
| GS1 | 20190752152325 [Package] Contains: 50190752152326 Package: Box [40 Units] In Commercial Distribution |
| GS1 | 50190752152326 [Package] Contains: 10190752152328 Package: Case [160 Units] In Commercial Distribution |
| GS1 | 70190752152320 [Package] Contains: 20190752152325 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 | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-12-11 |
| Device Publish Date | 2021-04-09 |
On-Brand Devices [RediTube™]
| 50190752152432 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 20190752152424 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 70190752152412 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 70190752152405 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 20190752152363 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 20190752152349 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 20190752152332 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 70190752152320 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 50190752148718 | Tracheal Tube Oral/Nasal with Pre-loaded Stylet |
| 50190752148701 | 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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