Who else makes this device?

Name: LF
Brand: LF

LF · Injector, Contrast Medium, Automatic → Cardiovascular

1manufacturer

16catalogue numbers in this listing

1510(k) clearance

3recalls on this code

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code IZQ
Manufacturer	City	Province	Registered as	Device types
Vincent Medical (Dong Guan) Manufacturing Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	29

Record

Regulatory record for LF
Listed by	Liebel-Flarsheim Company LLC, United States
FDA product code	IZQ
Device type	Injector, Contrast Medium, Automatic
Device class	Class 2
Regulation	21 CFR 870.1650
Establishment	Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer
510(k)	K063503
Record published	2016-09-09
Record revised	2023-12-04 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, serial number
Sizes	Length 20 ft; length 6 m
Distribution end date	2025-10-20

Catalogue Numbers

Catalogue numbers for LF
Catalogue number	Size	Status
844007		In distribution
844200		In distribution
844005		In distribution
847002		In distribution
849001		In distribution
847003		In distribution
802622	Length 20 ft	In distribution
849002		In distribution
844210		In distribution
DL844005		Withdrawn
849001C		Withdrawn
DS844005		Withdrawn
847003C		Withdrawn
DE844005		Withdrawn
DL844003		Withdrawn
849002C		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ulrich medical disposables	Ulrich Gmbh & Co. KG	9
Injector, Contrast Medium, Automatic	Ulrich Gmbh & Co. KG	5
ulricheasyINJECT Max	Ulrich Gmbh & Co. KG	3
Remote Control	Bracco Injeneering	3
Floor Stand	Bracco Injeneering	3
FastLoad™ MR Syringe Pack	Bracco Injeneering	3
EmpowerCTA®+ Injector System	Bracco Injeneering	3
Medrad® Stellant Flex Syringe Kit	Bayer Medical Care Inc.	3
Hydraulic Controller	Bracco Injeneering	2
Day Set III HP	Bracco Injeneering	2
EmpowerMR® Injector System without Remote Control	Bracco Injeneering	2
Medrad XDS Extravasation Detection System	Bayer Medical Care Inc.	2

Showing 12 of 38. All products under Injector, Contrast Medium, Automatic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K152361	2016-01-14

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of LF
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Liebel-Flarsheim Company LLC	510(k) number	2008-04-07	Not classified	Component design/selection	Screws can begin to loosen and shear off to the point of the J-Bow falling from the suspension system. This may cause injury to patients or hospital staff.	783 Units	2011-05-20

Recalls

The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2011-10-11	Not classified	Packaging	Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena 150mL Syringe with Handi-Fil Straw, product 900101.	187,400 units (900103 syringe: 129,200; 900101 syringe: 58,2	2013-07-19
2011-05-20	Not classified	Other	Syringes packaged and labeled as the Illumena 150mL Linden Luer Syringe with Handi-Fil Straw, product 900103, contained the Illumena150mL Syringe with Handi-Fil Straw, product 900101.	11,000 units (200 cases/50 units per case)	2013-02-19

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

LF