RediTube™ 8045RTC
GUDID 10885403295881
RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet
Carefusion Corporation
Basic endotracheal tube, single-use| Primary Device ID | 10885403295881 |
| NIH Device Record Key | 4249ae0d-231f-427f-adcb-98531257432c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RediTube™ |
| Version Model Number | 8045RTC |
| Catalog Number | 8045RTC |
| Company DUNS | 830432451 |
| Company Name | Carefusion Corporation |
| 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 | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com | |
| Phone | 800.323.9088 |
| gmb-MedSpec-CustService@carefusion.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
| Lumen/Inner Diameter | 4.5 Millimeter |
| Outer Diameter | 6.2 Millimeter |
| Device Size Text, specify | 0 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 49 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10885403295881 [Primary] |
| GS1 | 20885403295888 [Package] Contains: 70885403295883 Package: BOX [2 Units] In Commercial Distribution |
| GS1 | 50885403295889 [Package] Contains: 20885403295888 Package: CS [4 Units] In Commercial Distribution |
| GS1 | 70885403295883 [Package] Package: PAK [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 | 3 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2016-08-29 |
On-Brand Devices [RediTube™]
| 10885403296178 | Vital Signs® Tracheal Tube Oral/Nasal |
| 50885403296145 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 10885403296123 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403296107 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403296084 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403296060 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 10885403296048 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403296022 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403296008 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403295971 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403295964 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 10885403295935 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 10885403295928 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403295896 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 10885403295881 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403295858 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403295841 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 50885403295810 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
| 10885403295799 | RediTube™ Tracheal Tube Oral/Nasal with Preloaded Stylet |
Trademark Results [RediTube]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REDITUBE 75332234 2186986 Dead/Cancelled |
High Standard Products Corporation 1997-07-29 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.