FDA UDI
In Commercial Distribution
🇺🇸 United States
07-150-08 Mizuho Doppler 8 MHz Dual Channel, AC Power
DI: 00817122020409
·
Model: 128910-AC
·
VASCULAR TECHNOLOGY, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- 07-150-08 Mizuho Doppler 8 MHz Dual Channel, AC Power
- Primary DI
- 00817122020409
- Version / Model
- 128910-AC
- Catalog Number
- 128910-AC
- Company Name
- VASCULAR TECHNOLOGY, INCORPORATED
- Labeler DUNS
- 161989343
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f1ec5097-9ed3-48d6-a600-a7f05881a731
Device Description
Part Number 128910-AC, 07-150-08 Mizuho Doppler 8 MHz, Dual Channel AC Power
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| DPW | FLOWMETER, BLOOD, CARDIOVASCULAR | Cardiovascular | 870.2100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61236 | Vascular ultrasound system control unit | A mains electricity (AC-powered) external device, which may include internal rechargeable batteries, intended to be used to indicate (visually and/or sonically) blood flow in a peripheral blood vessel, through connection to a dedicated probe/catheter (not included), using ultrasound/Doppler/transit time technology. It may be intended to locate and assess the extent of vascular flow restriction (e.g., clots, stenosis, mechanical damage) or to monitor blood flow in association with microvascular surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817122020409 | 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