FDA UDI
In Commercial Distribution
🇺🇸 United States
Portex
DI: 15019315107283
·
Model: 100/386/010CZ
·
Smiths Medical Czech Republic a.s.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Portex
- Primary DI
- 15019315107283
- Version / Model
- 100/386/010CZ
- Company Name
- Smiths Medical Czech Republic a.s.
- Labeler DUNS
- 361330253
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-06-22
- Public Version
- 1
- Public Version Date
- 2020-06-30
- Public Version Status
- New
- Public Device Record Key
- a2425617-431c-428b-bf85-58655644c696
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 |
|---|---|---|---|---|---|---|
| Package | 35019315107287 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 15019315107283 | GS1 | ||||
| Package | 55019315107281 | GS1 | Pallet | 7 | In Commercial Distribution |