FDA UDI
In Commercial Distribution
🇺🇸 United States
Portex
DI: 15019315052644
·
Model: 100/856/090
·
Smiths Medical International Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Portex
- Primary DI
- 15019315052644
- Version / Model
- 100/856/090
- Company Name
- Smiths Medical International Ltd
- Labeler DUNS
- 215591523
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-01
- Public Version
- 4
- Public Version Date
- 2020-12-08
- Public Version Status
- Update
- Public Device Record Key
- d78bdd43-3d02-43d2-9fbb-d494a69d2018
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| BTO | Tube, tracheostomy (w/wo connector) | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14089 | Tracheostomy tube cannula, single-use | A sterile, hollow, cylindrical, curved device designed as an internal, independent component of a metal or plastic tracheostomy tube. It is made of plastic and has precise dimensions allowing it to fit exactly into the outer tube and function as the inner cannula for tracheostomy tubes that have this kind of function. It is removed once or more times daily to facilitate the removal of phlegm, slime, and contamination build-up, thereby preventing blockage and infection of the stoma and eliminates the traumatic removal of the tracheostomy tube. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35019315052648 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 15019315052644 | GS1 | ||||
| Package | 55019315052642 | GS1 | Pallet | 3 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K030381 | 000 |