FDA UDI
In Commercial Distribution
🇺🇸 United States
Invotec Tracheal T-Tube
DI: 00818501020065
·
Model: 1
·
INVOTEC INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Invotec Tracheal T-Tube
- Primary DI
- 00818501020065
- Version / Model
- 1
- Catalog Number
- 70-50081
- Company Name
- INVOTEC INTERNATIONAL, INC.
- Labeler DUNS
- 622812592
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-03
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b4c514e5-245d-46ac-87fa-164d27c47f43
Device Description
Invotec Tracheal T-Tube, Non-Sterile, 8.0cm Long
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 |
|---|---|---|---|---|
| 62136 | Laryngectomy tube, non-sterile | A non-sterile hollow device intended to maintain tracheostoma patency after laryngectomy to provide an airway for the patient and to prevent tracheostomal stenosis in the months following the procedure. It is a soft plastic or silicone curved tube, similar to a tracheostomy tube, contoured to fit the postoperative tracheal anatomy, and may have an inner cannula and be fenestrated to allow simultaneous use with a tracheoesophageal speech valve. It is held in place with a strap or band around the neck and is typically regularly removed and reinserted by the patient. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818501020065 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930114 | 000 |