FDA UDI
In Commercial Distribution
🇺🇸 United States
Portex
DI: 10351688426352
·
Model: 008201
·
SMITHS MEDICAL MD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Portex
- Primary DI
- 10351688426352
- Version / Model
- 008201
- Company Name
- SMITHS MEDICAL MD, INC.
- Labeler DUNS
- 106712748
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-23
- Public Version
- 1
- Public Version Date
- 2021-03-03
- Public Version Status
- New
- Public Device Record Key
- 054134b9-a805-4094-9ca6-4293bb8d885c
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CAP | MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM) | Anesthesiology | 868.2600 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46634 | Airway pressure monitor, non-powered | A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30351688428350 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 10351688426352 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K961318 | 000 |