FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Clamp-On Transducer
DI: 04062114000082
·
Model: 12133
·
em-tec GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Clamp-On Transducer
- Primary DI
- 04062114000082
- Version / Model
- 12133
- Catalog Number
- 12133
- Company Name
- em-tec GmbH
- Labeler DUNS
- 320025190
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-20
- Public Version
- 1
- Public Version Date
- 2018-10-22
- Public Version Status
- New
- Public Device Record Key
- 3f39da63-c59d-4e44-8d1f-c12fa6d5fff8
- Distribution End Date
- 2018-09-20
Device Description
Clamp-on Transducer: The SonoTT Clamp-on Transducer measures flow in extracorporeal tubing systems. The sensor is clamped on to the tubing by a simple click closure device and measurements are made non-invasively. The measurement method can be used for extracorporeal circulation systems such as heart-lung machines or ECMO/ECLS applications. The sensors are available in different sizes for all conventional tubing sizes. A customer-specific calibration of the sensor guarantees the highest measurement precision and complete reliability.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61422 | Noninvasive vascular ultrasound system, line-powered | A mains electricity (AC-powered) device assembly consisting of a desktop unit, a graphical display unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. Clinical applications include venous/arterial flow screening (e.g., assessment of air embolism, atherosclerosis, varicose veins, venous thrombosis), ankle pressure index, and/or blood flow wave form recording. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04062114000082 | GS1 |
Customer Contacts
- Phone
- +49880692360
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K111730 | 000 |