FDA UDI
In Commercial Distribution
🇺🇸 United States
Total Control Introducer™ (TCI)
DI: 00860581002639
·
Model: 000163
·
Through The Cords, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Total Control Introducer™ (TCI)
- Primary DI
- 00860581002639
- Version / Model
- 000163
- Company Name
- Through The Cords, LLC
- Labeler DUNS
- 080585251
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- 1a6c5193-01d8-4016-b170-5cee86553b4b
- Distribution End Date
- 2024-08-13
Device Description
Articulating Introducer with detachable handle, intuitive depth system, 70 CM, 15 Fr, latex free, single use, sterile, fits 6.0 and larger ID tubes
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
- Yes
- 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 |
|---|---|---|---|---|
| BSR | Stylet, Tracheal Tube | Anesthesiology | 868.5790 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41829 | Endotracheal tube introducer, single-use | A device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, typically angled at the distal end, designed to improve directional control of the endotracheal tube during routine or difficult oral intubations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860581002639 | GS1 | ||||
| Package | 00860581002646 | GS1 | Box | 5 | Not in Commercial Distribution | |
| Package | 00860581002653 | GS1 | Case | 20 | Not in Commercial Distribution |
Customer Contacts
- Phone
- 801-917-3851
- [email protected]