C-Quest

C-Quest is a blood collection device that separates the first portion of a blood draw from the sample collected for testing. It combines a valved tee body, a universal culture tube holder…

Registry build 21.09.26

C-Quest is a blood collection device that separates the first portion of a blood draw from the sample collected for testing. It combines a valved tee body, a universal culture tube holder and a 5 mL diversion syringe.

The user draws the initial blood into the diversion syringe. A one-way check valve in the tee body keeps that blood isolated, while the subsequent sample follows a separate flow path into a blood culture bottle or collection syringe.

Listed Item

5mL Luer Lock Blood Diversion Syringe, Valved Tee w/Spinner, Universal Bottle Holder, Extension Set w/NIV

Collection Setup

C-Quest connects to a scalp vein set for venipuncture or to an existing intravenous line through an extension set. Its diversion volume is 1.5 to 2.0 mL. The device is sterilized with ethylene oxide and intended for a single collection procedure; its components are not intended for infusion.

23manufacturers in China registered for this device type
4catalogue numbers in this listing
1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (7), Zhejiang (6), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JKA
Manufacturer City Province Registered as Device types
Promisemed Hangzhou Meditech Co., Ltd. Hangzhou Zhejiang Contract manufacturer 21
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13
Weihai Jierui Medical Products Co., Ltd. Weihai Shandong Contract manufacturer 3
Tianjin Hanaco Medical Co., Ltd. Tianjin Tianjin Contract manufacturer 3
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Zhejiang Medicines & Health Products I/ E Co., Ltd. Hangzhou Zhejiang Exporter 41
Jiangsu Caina Medical Co., Ltd. Jiangyin Jiangsu Contract manufacturer 20
Hangzhou Best Valley Medical Technology Co., Ltd. Hangzhou Zhejiang Exporter 20
Zhejiang Kindly Medical Devices Co., Ltd. Wenzhou Zhejiang Contract manufacturer 16
Jiangsu Rongye Technology Co., Ltd. Yangzhou Jiangsu Manufacturer 16
Yangzhou Medline Industry Co., Ltd. Yangzhou Jiangsu Contract manufacturer 11
Shanghai Mekon Medical Devices Co., Ltd. Shanghai Shanghai Exporter 11

Showing 12 of 23. All 23 manufacturers in China registered for Tubes, Vials, Systems, Serum Separators, Blood Collection

Record

Regulatory record for C-Quest
Listed by Lifeoutcomes, LLC, United States
FDA product code JKA
Device type Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class Class 2
Regulation 21 CFR 862.1675
510(k) K231282
Record published 2026-07-09

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Pack of 50

Catalogue Numbers

Catalogue numbers for C-Quest
Catalogue number Size Status
40-200 In distribution
40-250-PR-UT In distribution
40-200-21A In distribution
40-250-PR In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Portex ICU Medical, Inc 182
S-Monovette® Sarstedt Aktiengesellschaft & Co.KG 108
Vacuette Greiner BIO-ONE Gmbh 106
Jelco ICU Medical, Inc 35
Kbmed KB Medical (Group) Inc. 33
Marketlab Inc Marketlab Incorporated 30
Maveric Medical Maveric Medical LLC 27
Safe-T-Fill® Ram Scientific 23
Improvacuter® Gel & Clot Activator Tube Guangzhou Improve Medical Instruments Co., Ltd. 21
Medline Medline Industries, Inc. 20
Kurin Blood Culture Collection Set Kurin, Inc. 20
Reli Myco Medical Supplies, Inc. 18

Showing 12 of 303. All products under Tubes, Vials, Systems, Serum Separators, Blood Collection

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K231282 2024-01-26

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer