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Rayflow

FDA UDI

Class II (US FDA UDI)

by Hexacath

Identity

Trade Name
RAYFLOW FDA UDI
Generic Name
Coronary artery infusion catheter FDA UDI
Device Name
Multipurpose infusion catheter Rayflow FDA UDI
Model / Reference
RFW62U FDA UDI
Description
Multipurpose infusion catheter Rayflow FDA UDI

Identifiers

Primary DI / UDI-DI
03700385769154 FDA UDI
510(k) Number
K222023 FDA UDI
FDA Product Code
KRA FDA UDI
DQO FDA UDI
GMDN Term
Coronary artery infusion catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1210 FDA UDI
870.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coronary artery infusion catheter

Rayflow by Hexacath — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coronary artery infusion catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Hexacath

Sources (1)

  • FDA UDI 7e951635-9399-4c94-80eb-9c27e4cc91fe 35 fields · synced May 30, 2026