FDA UDI
In Commercial Distribution
🇺🇸 United States
CooperSurgical®
DI: 00888937027792
·
Model: DP-SDP001
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- CooperSurgical®
- Primary DI
- 00888937027792
- Version / Model
- DP-SDP001
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-23
- Public Version
- 1
- Public Version Date
- 2026-02-02
- Public Version Status
- New
- Public Device Record Key
- 3ac1fd51-f685-4d4c-b863-aa0948e71cff
Device Description
Swartz Doppler Probe
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18673 | Blood flowmeter catheter, Doppler | A device that is a flexible tube designed for insertion within the blood vessels for the purpose of determining blood-flow velocity by measuring the ultrasonic frequency shift between the transmitted and reflected signals (Doppler principle). It typically has a ceramic crystal attached at or near its distal tip that is capable of both transmitting and receiving ultrasound signals [20 megahertz (MHz) frequency is typical]. The proximal end is connected to a Doppler blood flowmeter unit where the measurements are displayed. It is typically used for measurement of the coronary haemodynamics (e.g., blood mean and peak velocity) during coronary procedures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00888937027792 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171272 | 000 |