FDA UDI
In Commercial Distribution
🇺🇸 United States
Portex
DI: 15019315022371
·
Model: 100/199/095
·
Smiths Medical International Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Portex
- Primary DI
- 15019315022371
- Version / Model
- 100/199/095
- Company Name
- Smiths Medical International Ltd
- Labeler DUNS
- 215591523
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-01
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 0022e427-21d3-44e7-9496-5a71e6710502
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
- Yes
- 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 |
|---|---|---|---|---|
| BTR | Tube, tracheal (w/wo connector) | Anesthesiology | 868.5730 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46976 | Surgical mallet head | A device intended to replace the head of some types of surgical mallets and hammers. It is typically a solid cylinder of various diameters with flat ends; it is made of durable, non-splintering, synthetic polymer materials and is fixed (typically screwed using it's central screw thread) to the the distal end of the mallet. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 35019315022375 | GS1 | BOX | 20 | In Commercial Distribution | |
| Primary | 15019315022371 | GS1 | ||||
| Package | 55019315022379 | GS1 | CASE | 6 | In Commercial Distribution |