FDA UDI
In Commercial Distribution
🇺🇸 United States
Portex
DI: 15019517046182
·
Model: 101/506/030
·
SMITHS MEDICAL MD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Portex
- Primary DI
- 15019517046182
- Version / Model
- 101/506/030
- Company Name
- SMITHS MEDICAL MD, INC.
- Labeler DUNS
- 106712748
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-21
- Public Version
- 5
- Public Version Date
- 2020-06-05
- Public Version Status
- Update
- Public Device Record Key
- c867a210-44a5-4754-a785-d656ad44509d
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
- MR Safe
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JOH | Tube tracheostomy and tube cuff | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35404 | Tracheostomy tube, non-reinforced, non-customized, single-use | A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35019517046186 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 15019517046182 | GS1 | ||||
| Package | 55019517046180 | GS1 | CARTON | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170720 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Circumference | 3 | Millimeter | |
| Device Size Text, specify | 3.0mm |