FDA UDI
In Commercial Distribution
🇺🇸 United States
Portex
DI: 15019517078763
·
Model: 24-1018-64
·
Smiths Medical ASD, Inc.
Product Codes
4
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Portex
- Primary DI
- 15019517078763
- Version / Model
- 24-1018-64
- Company Name
- Smiths Medical ASD, Inc.
- Labeler DUNS
- 082005361
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-03-09
- Public Version
- 2
- Public Version Date
- 2020-11-19
- Public Version Status
- Update
- Public Device Record Key
- 09a7d62d-ad8b-44ac-b2ea-15ed05e442a7
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 |
| MIA | NEEDLE, SPINAL, SHORT TERM | Anesthesiology | 868.5150 | 2 |
| CAZ | Anesthesia conduction kit | Anesthesiology | 868.5140 | 2 |
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | Anesthesiology | 868.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44884 | Low-resistance epidural syringe | A low-friction glass or plastic barrel (cylinder) with plunger intended to be used with a needle typically to locate the epidural space. The user advances the needle until a loss of resistance (LOR) is sensed in the plunger, indicating entry into the epidural space. The syringe may then be disconnected to allow the introduction of a catheter through the needle for diagnostic or therapeutic intervention. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35019517078767 | GS1 | Case | 50 | In Commercial Distribution | |
| Primary | 15019517078763 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172410 | 000 |