FDA UDI
Not in Commercial Distribution
🇺🇸 United States
RediTube™
DI: 10190752148741
·
Model: 8065RTC
·
AIRLIFE
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- RediTube™
- Primary DI
- 10190752148741
- Version / Model
- 8065RTC
- Catalog Number
- 8065RTC
- Company Name
- AIRLIFE
- Labeler DUNS
- 119058668
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-02
- Public Version
- 5
- Public Version Date
- 2025-05-02
- Public Version Status
- Update
- Public Device Record Key
- 13cdeb33-6b8a-490d-912e-ff47bd209c2e
- Distribution End Date
- 2025-05-02
Device Description
Tracheal Tube Oral/Nasal with Pre-loaded Stylet
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BTR | Tube, tracheal (w/wo connector) | Anesthesiology | 868.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46967 | Basic endotracheal tube, single-use | A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50190752148749 | GS1 | Case | 160 | Not in Commercial Distribution | 2025-05-02 |
| Primary | 10190752148741 | GS1 | ||||
| Package | 20190752148748 | GS1 | Box | 40 | Not in Commercial Distribution | 2025-05-02 |
| Package | 70190752148743 | GS1 | Pack | 20 | Not in Commercial Distribution | 2025-05-02 |
Customer Contacts
- Phone
- +1(833)327-3284
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K042683 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry
- Type
- Storage Environment Temperature
- Temperature Range
- High: 49 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight