Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Who Makes This Device Type in China?

13 manufacturers in China hold an FDA registration for this device type, concentrated in Beijing, Jiangsu and Guangdong, and 4 other provinces. 3 of them are contract manufacturers, able to build to a buyer’s own specification.

Beijing Demax Medical Technology Co., Ltd. Beijing
Boen Healthcare Co., Ltd. Jiangsu
Beijing Target Medical Technologies Inc. Beijing, contract manufacturer
Curatia Medical Limited Jiangsu
Elite Medtek(Jiangsu) Co., Ltd. Jiangsu, contract manufacturer
Joykey Industrial (Pinghu) Limited Zhejiang, contract manufacturer
Lepu Medical Technology (Beijing) Co., Ltd. Beijing
Shandong INT Medical Instruments Co., Ltd. Shandong
Sunny Medical Device (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
Shanghai INT Medical Instruments Co., Ltd. Shanghai, contract manufacturer
Tianck Medical Co., Ltd. Guangdong
Tianjin Demax Medical Technology Co., Ltd. Tianjin, contract manufacturer
Zhejiang Mediunion Healthcare Group Co., Ltd. Zhejiang, contract manufacturer

What Is FDA Product Code DTL?

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass is FDA product code DTL, Class 2, 21 CFR 870.4290.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Do the Recalls Say?

The FDA has recorded 59 recalls under this product code since 2006. None was by a company in China. 6 are Class I, the most serious grade.

The root causes the FDA records most often are Packaging process control (24), Process control (8) and Equipment maintenance (6). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Namic

MTO Manifold Morse CL.4V 200 RH/OFF-PKG

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Contrast Line

Contrast Line 60"(152cm) Female/Rotating Adapter Polyurethane, Braided 1200 PSI

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Merit® Manifold

119 catalogue numbers from 00884450034200, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Connector

70 catalogue numbers from AX-xxxxx, listed by LivaNova USA, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

DeRoyal

Manifold 2 Port Left Hand ONHalf Body High Pressure

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Marquis® Stopcock

40 catalogue numbers from 00884450085400, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cook

Connecting Tube Female to Male Luer Lock

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Intersept®

Conn RED 6109 3/16 X 1/4 W/Luer LOCK20PK

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Connector, 3/8″ Perfusion Adapter

2 catalogue numbers from 301010-000, listed by Novosci Corp., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

DLP®

Adapter 14031 Mult Perf SET Vent 10P 17L

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Namic

NAMIC Standard Peripheral Vascular Angiographic Kit Portection Station with Radiology Control Syringe and flexCIL

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Sunmed Haemostatic Valves

Catalogue number 7F, Push-pull, Sideon Tubing and Stopcoc, listed by Sunny Medical Device (Shenzhen) Co., Ltd., China, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Medline Industries, Inc.

KIT Manifold Cstm - River City

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Demax

60 catalogue numbers from DPY01B, listed by Beijing Demax Medical Technology Co., Ltd., China, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Unbranded

Pressure Monitoring line

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

StandTall

Sheath Extender and Securement Clasp, 25cm

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Connector, 1/4″X 3/8″ X 3/8″ Clear PAY

Catalogue number 321233-000, listed by Novosci Corp., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Connector, 3/8″X 1/2″ X 3/8″ Clear PAY

Catalogue number 321343-000, listed by Novosci Corp., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Angioway

6 catalogue numbers from LP-P-30S-YNRH, listed by Lepu Medical Technology (Beijing) Co., Ltd., China, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

DoublePlay™

6 catalogue numbers from 00884450011355, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Manifold

2 Port Manifold w/6" Ext. Right/Off/Finger Grip - 200 PSI

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Valve 6248VAL Adjustable Hemostasis

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Piton™ Y-Pack

Y-Adapter AC4003M Piton TJM 5PK

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

AccessPLUS™

14 catalogue numbers from 00884450022078, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

IV Plus

3-Way Stopcock with Vented Caps

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Contrast Injection Line

Contrast Injection Line 48" (122cm) M/F (PVC) 1000 PSI

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Manifold

Right off 500PSI

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

H. Lee SafeSheath® Sealing Adapter

3 catalogue numbers from 00884450162132, listed by Merit Medical, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

PhD™

14 catalogue numbers from 00884450160503, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FLO50™

4 catalogue numbers from 00884450322284, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Access-9™

8 catalogue numbers from 00884450022061, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Prelude Choice™

2 catalogue numbers from 00884450393154, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

INT

Push-Rotate Y connector with 15 cm extension tube,45 psi stopcock, torque device, insertion tool;

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

3 Port Manifold – Left/Off/Open Body – 500 PSI

Catalogue number 193123, listed by Argon Medical Devices, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Ariss®

Adapter 13004 Ariss Switch Table 10P 17L

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Vygon

Ramp of stopcocks Luer-lock with extension tube L.50cm - 4 one-way stopcocks

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

FLO40XR™

4 catalogue numbers from 00884450723111, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Guardian

Guardian II Model 8211, Pouch Label, US, TCT

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Medline

STOPCOCK,3-WAY,1050,PSI,HIGH Off,rot,l/L

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

1/2″ Coronary Perfusion Plug

1/2" Tubing TO FIT Over THE Coronary Perfusion Oultet Port OF AN Oxygenator, TO Securely Seal OFF THE Port, Thus Reducing THE Possibility OF THE Port Being Inadvertently Opened During THE…

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Disposable Stopcock, Three-WAY Luer Lock, Blue, Sterile

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Overpressure Safety Valve

Catalogue number LH130, listed by Terumo Cardiovascular Systems Corporation, United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Guardian® II NC Hemostasis Valve

The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal…

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Connector, 3/8″X 3/8″ X 1/2″ Clear PAY

2 catalogue numbers from 321334NS, listed by Novosci Corp., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

CPS H. Lee SafeSheath® Sealing Adapter

2 catalogue numbers from 00884450505397, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

MBAplus™

Catalogue number 00884450668764, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Connector

DMA 1000 Dual Male Adapter

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

10fore™

Catalogue number Initial Release, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Tram®

Catalogue number 00884450312353, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Manifold

VGAM0301 Manifold

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Hemostasis Valve Adapter

2 catalogue numbers from GWT-001-00, listed by Galt Medical Corp., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Merit Medical®

7 catalogue numbers from 00884450053904, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Piton™ TRI-Adaptor

Adapter AC4002M TRI W/Metal Gdwr 5PK

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Tram®p

4 catalogue numbers from 00884450312414, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Honor®

13 catalogue numbers from 00884450664223, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Three Way Stopcock

2 catalogue numbers from ST-01, listed by Tianck Medical Co., Ltd., China, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Five Stopcock Manifold

Catalogue number 041275501A, listed by Argon Medical Devices, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Stopcocks

Stopcocks (North Carolina Baptist Hospital Winston-Salem, NC)

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Connector, 1/2″X 1/2″ X 1/2″ Clear PAY

Catalogue number 321444-000, listed by Novosci Corp., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Pediatric Tubing Organizer – Sterile

A small, sterile device with a locking/holding mechanism designed to secure most any kind of tubing or tubing-like device (e.g., cables, cords) to a patient or to a surgical drape during a…

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Passage®

Passage®: 6 catalogue numbers listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Medex

5 catalogue numbers from MX1336LB, listed by ICU Medical, Inc, United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Overpressure Safety Valve – Japan

Catalogue number LH130J, listed by Terumo Cardiovascular Systems Corporation, United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

V. Mueller

Ayer Stopcock Female Luer-Lock TO Male Luer Slip Plus Female Luer-Lock Right Side Connection

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Check-Flo

Check-Flo Hemostasis Assembly

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

MBA™

8 catalogue numbers from 00884450024430, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Quickie Prime – 1/4″X 3/32″

2 catalogue numbers from 301012NS, listed by Novosci Corp., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Quickie Prime – 24″ W/Clamp

Catalogue number 301124-000, listed by Novosci Corp., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Monitoring Kit

Monitoring Kit - St Louis University

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Spike

Catalogue number Spike, listed by LivaNova USA, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Connector, 1/4″X 1/4″ X 3/8″ Clear PAY

2 catalogue numbers from 321223NS, listed by Novosci Corp., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Guardian® II Hemostasis Valve

The Guardian hemostasis valves are intended to maintain hemostasis during the use of diagnostic or interventional devices. Guardian hemostasis valves are indicated for maintaining a seal…

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

H. Lee SafeSheath® Sealing Adapter

3 catalogue numbers from 00884450505380, listed by Merit Medical Systems, Inc., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Spike, Blood W/ 1/4″ Connector Cover

A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end…

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Connector, 1/4″ Perfusion Adapter

2 catalogue numbers from 301009-000, listed by Novosci Corp., United States, under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass. 13 manufacturers in China are registered for this product code.

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Venous Catheter, two-stage, SLIM, complete reinforcement, elliptic proximal body, Lighthouse tip, with connector

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Who Makes This Device Type in China?

What Is FDA Product Code DTL?

What Does It Take to Sell It in the United States?

What Do the Recalls Say?

Where China Actually Supplies