Monoject

Blood Collection/Infusion Set,Multi-Sample Luer Adapter, 12 inch (30.5 cm) Tubing

Registry build 21.09.26
12manufacturers in China registered for this device type
13catalogue numbers in this listing

Who Else Makes It

Concentrated in Shandong (3), Guangdong (3), Jiangsu (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FOZ
Manufacturer City Province Registered as Device types
Amsino Medical (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 22
Bioxin Medical Co., Ltd. Weihai Shandong Contract manufacturer 8
Weihai Jierui Medical Products Co., Ltd. Weihai Shandong Contract manufacturer 3
Becton Dickinson Medical Devices Co., Ltd. Suzhou Suzhou Jiangsu Contract manufacturer 2
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Zhejiang Kindly Medical Devices Co., Ltd. Wenzhou Zhejiang Contract manufacturer 16
Terumo Medical Products (Hangzhou) Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Shandong Ande Healthcare Apparatus Co., Ltd. Zibo Shandong Manufacturer 7
Jiangxi Sanxin Medtec Co., Ltd. Nanchang Jiangxi Manufacturer 6
Haolang Technology (Foshan) Limited Corporation Foshan Guangdong Contract manufacturer 6
Guangdong Baihe Medical Technology Co., Ltd. Foshan Guangdong Contract manufacturer 4
Foshan Special Medical Co., Ltd. Foshan Guangdong Manufacturer 3

Record

Regulatory record for Monoject
Listed by Cardinal Health, United States
FDA product code FOZ
Device type Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class Class 2
Regulation 21 CFR 880.5200
Establishment Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k) K912563
Record published 2016-09-24
Record revised 2024-11-01 (version 11)

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
Storage Special storage condition: ;
Packaging Case of 50
Distribution end date 2026-09-16

Catalogue Numbers

Catalogue numbers for Monoject
Catalogue number Size Status
8881225182 Needle Gauge,21,Gauge;Length,12 (tubing) and 3/4 (needle),Inch; In distribution
8881225220 In distribution
8881225208 Needle Gauge,25,Gauge;Length,12 (tubing) and 3/4 (needle),Inch; In distribution
8881225174 Needle Gauge,19,Gauge;Length,12 (tubing) and 3/4 (needle),Inch; In distribution
8881225307 Needle Gauge,23,Gauge;Length,12 (tubing) and 3/4 (needle),Inch; In distribution
8881225299 Needle Gauge,21,Gauge;Length,12 (tubing) and 3/4 (needle),Inch; In distribution
8881225221 Needle Gauge,21,Gauge;Length,12 (tubing) and 3/4 (needle),Inch; In distribution
8881225390 Needle Gauge,23,Gauge;Length,3 (tubing) and 3/4 (needle),Inch; In distribution
8881225315 Needle Gauge,25,Gauge;Length,12 (tubing) and 3/4 (needle),Inch; In distribution
8881225707 Needle Gauge,23,Gauge;Length,7 (tubing) and 3/4 (needle),Inch; In distribution
8881225190 Needle Gauge,23,Gauge;Length,12 (tubing) and 3/4 (needle),Inch; In distribution
8881225281 Needle Gauge,19,Gauge;Length,12 (tubing) and 3/4 (needle),Inch; In distribution
8881225119 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Arrow Teleflex Medical LLC 2,368
Cook Cook Incorporated 250
Cook Spectrum Cook Incorporated 225
Jelco ICU Medical, Inc 104
Medline Medline Industries, Inc. 95
Deltaven Fast Flash Delta Med SpA 77
Deltaven Delta Med SpA 73
PowerGlide Pro Bard Access Systems, Inc. 63
Peripheral Catheter Insertion Kit Bard Access Systems, Inc. 62
Able Central Venous Catheter Guangdong Baihe Medical Technology Co., Ltd. 62
Curaplex Bound Tree Medical, LLC 61
BD Cathena™ Safety IV Catheter Becton, Dickinson AND Company 59

Showing 12 of 285. All products under Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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