FDA UDI
In Commercial Distribution
🇺🇸 United States
Intuitive Depth Exchange™ Catheter (IDE)
DI: 00860581002660
·
Model: 000294
·
Through The Cords, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Intuitive Depth Exchange™ Catheter (IDE)
- Primary DI
- 00860581002660
- Version / Model
- 000294
- 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
- acbf4154-789d-455f-9cee-1fd89f2ce20b
Device Description
Exchange Catheter with intuitive colored depth system, 70 CM, 15 Fr, not made with natural rubber latex, 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 |
|---|---|---|---|---|
| 42084 | Endotracheal tube guide, single-use | A device used to provide guidance when it is necessary to exchange an endotracheal (ET) tube which has been intubated into a patient. The guide is inserted into the existing tube which is then retracted over the guide. The new ET tube is inserted over the guide to facilitate its correct passage, and the guide is removed once the new tube is satisfactorily in place. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00860581002677 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00860581002660 | GS1 | ||||
| Package | 00860581002684 | GS1 | Case | 100 | In Commercial Distribution |