Ballard™

BALLARD™ ORAL CARE SUCTION HANDLE, Suction Handle, For single patient use

Registry build 21.09.26
70manufacturers in China registered for this device type
16catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (22), Zhejiang (20), Guangdong (10). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JOL
Manufacturer City Province Registered as Device types
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Jiangsu JianYu Health Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 35
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Primecare Medical (Suzhou) Co., Ltd. Changshu Jiangsu Contract manufacturer 20
Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. Shuyang Jiangsu Contract manufacturer 18
Tylenol Medical Instruments Co., Ltd. Zhongshan Guangdong Contract manufacturer 15
VR Medical Technology Co., Ltd. Kunshan Jiangsu Contract manufacturer 13
Hangzhou Jinlin Medical Appliances Co., Ltd. Hangzhou Zhejiang Contract manufacturer 11
Ningbo Shengyurui Medical Appliance Co. Ningbo Zhejiang Contract manufacturer 11

Showing 12 of 70. All 70 manufacturers in China registered for Catheter And Tip, Suction

Record

Regulatory record for Ballard™
Listed by SunMed Group Holdings, LLC, United States
FDA product code JOL
Device type Catheter And Tip, Suction
Device class Class 2
Regulation 21 CFR 880.6740
Establishment Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2025-12-01
Record revised 2026-02-02 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Over the counter Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 25, case of 50, case of 4, case of 40, case of 24, case of 32
Sizes Catheter gauge 6 to 8 Fr

Catalogue Numbers

Catalogue numbers for Ballard™
Catalogue number Size Per pack Status
12603 In distribution
1221 Catheter Gauge 6 Fr 5 In distribution
33970 In distribution
1222 Catheter Gauge 8 Fr 5 In distribution
99785 In distribution
970008-5 In distribution
25929 In distribution
33971 In distribution
99790 In distribution
12601 In distribution
25930 In distribution
25928 In distribution
99787 In distribution
1223 5 In distribution
99789 In distribution
99786 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Millennium Avalign Technologies, Inc. 679
Gen2 Surgix Medical LLC 497
Avalign Avalign Technologies, Inc. 459
Ambler Surgical Ambler Surgical, LLC 369
Surtex Surtex Instruments Ltd 282
Integra® Ruggles®-Redmond™ Integra LifeSciences Production Corporation 281
V. Mueller Steris Corporation 230
Liposuction Cannula Sontec Instruments, Inc. 159
Pilling Teleflex Medical LLC 135
Medicon Medicon eG. Chirurgiemechaniker-Genossenschaft 127
Argyle Cardinal Health 200, LLC 125
Argyle Cardinal Health 117

Showing 12 of 397. All products under Catheter And Tip, Suction

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