Who else makes this device?

Name: CT Exprès Bottle Spike A
Brand: CT Exprès Bottle Spike A

Cardiovascular › DiagnosticInjector, Contrast Medium, Automatic

CT Exprès Bottle Spike A

Catalogue number 640458, listed by Acist Medical Systems, Inc., United States, under Injector, Contrast Medium, Automatic. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

2510(k) clearances naming this product 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 CT Exprès Bottle Spike A
Listed by	Acist Medical Systems, Inc., United States
FDA product code	IZQ
Device type	Injector, Contrast Medium, Automatic
Device class	Class 2
Regulation	21 CFR 870.1650
Establishment	Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K151048
Record published	2025-12-09

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied sterile	Yes
Single use	Yes
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date

Catalogue Numbers

Catalogue numbers for CT Exprès Bottle Spike A
Catalogue number	Size	Status
640458		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
LF	Liebel-Flarsheim Company LLC	16
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

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
K262115	2026-08-03
K984058	1999-02-11

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.