FDA UDI
In Commercial Distribution
🇺🇸 United States
Portex
DI: 15019315035562
·
Model: Z115-16
·
SMITHS MEDICAL ASD, INC.
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Portex
- Primary DI
- 15019315035562
- Version / Model
- Z115-16
- Company Name
- SMITHS MEDICAL ASD, INC.
- Labeler DUNS
- 137835299
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-19
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- fc946bd3-f297-4d94-9763-41ac3dc06394
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
- 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 |
|---|---|---|---|---|
| CAF | NEBULIZER (DIRECT PATIENT INTERFACE) | Anesthesiology | 868.5630 | 2 |
| BSY | CATHETERS, SUCTION, TRACHEOBRONCHIAL | Anesthesiology | 868.6810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34041 | Tracheobronchial suction/insufflation catheter, single-lumen | A sterile flexible tube designed for periodic tracheal and pharyngeal mucus aspiration and inflation of the lungs with a flow of gas from its distal tip. It consists of a single lumen tube for alternating suction and insufflation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35019315035566 | GS1 | CARTON | 20 | In Commercial Distribution | |
| Primary | 15019315035562 | GS1 |