FDA UDI
In Commercial Distribution
🇺🇸 United States
Mizuho 20 MHz Micro Disposable Doppler Probe, Box
DI: 10817122020222
·
Model: 108650
·
VASCULAR TECHNOLOGY, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
4
Basic Information
- Brand Name
- Mizuho 20 MHz Micro Disposable Doppler Probe, Box
- Primary DI
- 10817122020222
- Version / Model
- 108650
- Catalog Number
- 108650
- Company Name
- VASCULAR TECHNOLOGY, INCORPORATED
- Labeler DUNS
- 161989343
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2017-09-05
- Public Version
- 4
- Public Version Date
- 2021-04-07
- Public Version Status
- Update
- Public Device Record Key
- 6634015b-ff96-4c74-8ac7-4541bb2997b4
Device Description
Part Number 108650, VTI 20 MHz Micro Disposable Doppler Probe, Box
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
- No
- 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 |
|---|---|---|---|---|
| DPW | FLOWMETER, BLOOD, CARDIOVASCULAR | Cardiovascular | 870.2100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62211 | Invasive/noninvasive vascular ultrasound probe | A hand-operated component of a vascular ultrasound system intended to be used to measure the flow of blood both invasively by being applied to the outside of an isolated blood vessel perioperatively, and noninvasively by measuring flow in underlying vasculature from the body surface pre-/post-operatively, using ultrasonic/Doppler/transit time technology. It may also be used for cross-sectional visualization/imaging. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10817122020222 | GS1 | ||||
| Unit of Use | 00817122020225 | GS1 |
Customer Contacts
- Phone
- +1(603)594-9700
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082870 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry