FDA UDI
In Commercial Distribution
🇺🇸 United States
Runnels Steerable Introducer™ #4 Nasal
DI: 00850059297186
·
Model: 001050
·
Through The Cords, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Runnels Steerable Introducer™ #4 Nasal
- Primary DI
- 00850059297186
- Version / Model
- 001050
- Company Name
- Through The Cords, LLC
- Labeler DUNS
- 080585251
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-26
- Public Version
- 1
- Public Version Date
- 2024-02-05
- Public Version Status
- New
- Public Device Record Key
- d3bf1966-593d-4cb3-970f-b5147980f4fc
Device Description
Pre-lubricated articulating introducer with intuitive colored depth system, 77 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 |
|---|---|---|---|---|---|---|
| Package | 00850059297193 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 00850059297186 | GS1 | ||||
| Package | 00850059297209 | GS1 | Case | 20 | In Commercial Distribution |
Customer Contacts
- Phone
- 8019173851
- [email protected]