FDA UDI
In Commercial Distribution
🇺🇸 United States
Medi Choice
DI: 00888937010367
·
Model: MC150A-SD5
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Medi Choice
- Primary DI
- 00888937010367
- Version / Model
- MC150A-SD5
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-20
- Public Version
- 6
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 800c8b16-7b62-4c9c-b658-f338991ee4c1
Device Description
Non-Display Handheld Doppler with Audio Recorder and 5 MHz Vascular Probe (M150ASD5)
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| HEP | Monitor, Blood-Flow, Ultrasonic | Obstetrics/Gynecology | 884.2660 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44311 | Noninvasive vascular ultrasound system | An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937010367 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K024197 | 000 |