Identity
- Trade Name
- Cook-Swartz FDA UDI
- Generic Name
- Blood flowmeter catheter, Doppler FDA UDI
- Device Name
- COOK-SWARTZ DOPPLER FLOW PROBE - LONG CUFF EUDAMEDCook-Swartz Doppler Flow Probe Long Cuff FDA UDI
- Model / Reference
- DP-SDP002 EUDAMEDG03014 FDA UDI
- Description
- Cook-Swartz Doppler Flow Probe Long Cuff FDA UDI
Identifiers
- Catalog Number
- DP-SDP002 FDA UDI
- Primary DI / UDI-DI
- 00827002030145 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00827002030145 EUDAMED
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z12040111 BLOOD FLOW METERS EUDAMED
- GMDN Term
- Blood flowmeter catheter, Doppler FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Blood flowmeter catheter, Doppler
Cook-Swartz by Cook Vandergrift Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Blood flowmeter catheter, Doppler.
- FloWire Doppler Guide Wire XT 300cm 014 ST — VOLCANO CORPORATION · Class II
- FloWire Doppler Guide Wire XT 300cm 014 JTIP — VOLCANO CORPORATION · Class II
- FloWire Doppler Guide Wire XT 175cm 014 JTIP — VOLCANO CORPORATION · Class II
- Cook-Swartz — COOK VANDERGRIFT INC. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cook Vandergrift Inc.
Sources (2)
- FDA UDI 522a81f8-cebe-4f7a-aefc-5a83c81d9ff7 36 fields · synced Jul 14, 2026
- EUDAMED f61a2974-8ac4-44c2-82ca-7db9461ce6b0 61 fields · synced Jul 14, 2026