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Lf

FDA UDI

Class II (US FDA UDI)

by Liebel-Flarsheim Company, LLC

Identity

Trade Name
LF FDA UDI
Generic Name
Angiography kit FDA UDI
Device Name
CT Syringe (2) with Dual Check Valve Y-Tubing and Handi-Fil Straws; fits injector: OptiVantage FDA UDI
Model / Reference
844023 FDA UDI
Description
CT Syringe (2) with Dual Check Valve Y-Tubing and Handi-Fil Straws; fits injector: OptiVantage FDA UDI

Identifiers

Primary DI / UDI-DI
10746190002321 FDA UDI
510(k) Number
K042744 FDA UDI
FDA Product Code
DXT FDA UDI
GMDN Term
Angiography kit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1650 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Pressure — 2758 KiloPascal FDA UDI
Pressure — 400 Pound per Square Inch FDA UDI
Total Volume — 200 Milliliter FDA UDI

Category: Angiography kit

Lf by Liebel-Flarsheim Company, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Angiography kit.

Cleared under the same submission

K042744 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Liebel-Flarsheim Company, LLC

Sources (1)

  • FDA UDI 6af29f55-dc0c-4897-a4cb-4a62219258e0 35 fields · synced May 30, 2026