FDA UDI
Not in Commercial Distribution
🇺🇸 United States
DURATWIX
DI: 04051948033342
·
Model: 19611-10
·
Andreas Fahl Medizintechnik-Vertrieb GmbH
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DURATWIX
- Primary DI
- 04051948033342
- Version / Model
- 19611-10
- Company Name
- Andreas Fahl Medizintechnik-Vertrieb GmbH
- Labeler DUNS
- 314768383
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-09-17
- Public Version
- 4
- Public Version Date
- 2021-10-13
- Public Version Status
- Update
- Public Device Record Key
- 5b1ff407-3f1c-4126-acad-18570115211c
- Distribution End Date
- 2021-10-12
Device Description
DURATWIX UNI-VARIO CUFF 1 ICU + 1 ICV, SIZE 10
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | Anesthesiology | 868.5800 | 2 |
| JOH | Tube Tracheostomy And Tube Cuff | Anesthesiology | 868.5800 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38792 | Tracheostomy tube, non-reinforced, non-customized, reusable | A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04051948033342 | GS1 |
Customer Contacts
- Phone
- +49220329800
- [email protected]