FDA UDI
In Commercial Distribution
🇺🇸 United States
Portex
DI: 15019315023385
·
Model: 100/386/010
·
SMITHS MEDICAL ASD, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Portex
- Primary DI
- 15019315023385
- Version / Model
- 100/386/010
- Company Name
- SMITHS MEDICAL ASD, INC.
- Labeler DUNS
- 137835299
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-11
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- a1fe79b2-1ddc-4d2b-a6a3-12277815722a
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 |
|---|---|---|---|---|
| BSN | FILTER, CONDUCTION, ANESTHETIC | Anesthesiology | 868.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31245 | Anaesthesia conduction filter | A sterile microporous membrane used to minimize particulate (foreign material) contamination of a local anaesthetic during administration to a patient (e.g., through an anaesthesia conduction catheter). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 15019315023385 | GS1 | ||||
| Package | 35019315023389 | GS1 | BAG | 10 | In Commercial Distribution | |
| Package | 55019315023383 | GS1 | CARTON | 70 | In Commercial Distribution |