Medline

CATHETER,SUCTION,6FR,DELEE,STRT Pak,cali

Registry build 21.09.26
93manufacturers in China registered for this device type
49catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (29), Guangdong (28), Jiangsu (17). 16 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code BSY
Manufacturer City Province Registered as Device types
Shanghai Joy Crown Industry Co., Ltd. Pu Dong New Area Shanghai Contract manufacturer 64
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Amsino Medical (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 22
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
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Tylenol Medical Instruments Co., Ltd. Zhongshan Guangdong Contract manufacturer 15
Zhejiang Baite Medical Appliances Co., Ltd. Huzhou Zhejiang Contract manufacturer 13
Ningbo Great Mountain Medical Instruments Co., Ltd. Ningbo Zhejiang Contract manufacturer 12
Shenzhen Insighters Medical Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 10

Showing 12 of 93. All 93 manufacturers in China registered for Catheters, Suction, Tracheobronchial

Record

Regulatory record for Medline
Listed by Medline Industries, Inc., United States
FDA product code BSY
Device type Catheters, Suction, Tracheobronchial
Device class Class 1
Regulation 21 CFR 868.6810
Premarket notification Exempt
Record published 2020-05-01
Record revised 2026-07-06 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Over the counter Yes
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Storage Special storage condition: Avoid excessive heat. Protect from freezing.
Packaging Case of 20, carton of 10, pack of 10, case of 100, case of 10, case of 50
Sizes Catheter gauge 6 to 21.3 Fr
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Medline
Catalogue number Size Status
DYNDA1364A In distribution
DYND41960 In distribution
DYNCPTP14T In distribution
DYNCPDS12T In distribution
DYNCPDS14T In distribution
DYND41902 In distribution
DYND41906 In distribution
DYNCPDS16 In distribution
DYNCSDS14 Catheter Gauge 21.3 Fr In distribution
DYNCSTP14T Catheter Gauge 12 Fr In distribution
DYNCPE6 In distribution
DYNCPE7 In distribution
MDS876635 In distribution
DYNCSDS14T Catheter Gauge 12 Fr In distribution
DYND41904 In distribution
DYND41903 In distribution
MDS876636 In distribution
DYNCSTP14 Catheter Gauge 21.3 Fr In distribution
DYNCPDS16T In distribution
DYND41901 In distribution
DYND40990 In distribution
DYNCPY6 Catheter Gauge 6 Fr In distribution
DYND40992 In distribution
DYND40971 In distribution
DYNCSTP12 Catheter Gauge 21.3 Fr In distribution
DYND40974 In distribution
DYNDA2726 In distribution
DYNCPTP12 In distribution
DYNCPDS10 In distribution
DYNCPY8 Catheter Gauge 8 Fr In distribution
DYNCPTP16 In distribution
DYND40973 In distribution
DYNCPTP10T In distribution
DYND41964 In distribution
DYNCSDS12T Catheter Gauge 21.3 Fr In distribution
DYNCPDS10T In distribution
DYND41908 In distribution
DYND40978 In distribution
DYNCPTP14 In distribution
DYNCSTP12T Catheter Gauge 12 Fr In distribution
DYND40970 In distribution
DYNCPTP10 In distribution
DYNCPTP12T In distribution
DYNCPDS14 In distribution
DYNCPE5 In distribution
DYNCPTP16T In distribution
DYNDX41901 Catheter Gauge 12 Fr In distribution
DYNCPDS12 In distribution
DYNCSDS12 Catheter Gauge 21.3 Fr In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Ballard™ SunMed Group Holdings, LLC 214
Res-Q-Vac Repro-Med Systems, Inc. 201
DAR Covidien LP 185
Ballard* Closed Suction System for Adults Avanos Medical, Inc. 108
Suction Catheter Well Lead Medical Co., Ltd. 97
Avanos Avanos Medical, Inc. 63
Ballard* Closed Suction System Avanos Medical, Inc. 57
Ballard* Turbo-Cleaning Closed Suction System Avanos Medical, Inc. 57
ProCure Twin Med, LLC 47
AirLife™ Airlife, Inc. 44
Closed Suction Catheters Ningbo Xinwell Medical Technology Co., Ltd. 38
RespVac™ Cutting Edge HC Brands LLC 26

Showing 12 of 147. All products under Catheters, Suction, Tracheobronchial

Recalls Naming This Product

3 recalls name this product by its own identifiers, the UDI on its label.

Recalls naming the identifiers of Medline
Recalled by Identified by Initiated FDA class Root cause Reason Quantity
Medline Industries, LP – Northfield UDI-DI 2022-08-03 Class II Under Investigation by firm Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process 65,320 units
Medline Industries, LP – Northfield UDI-DI 2022-08-03 Class II Under Investigation by firm Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process 34,920 units
Medline Industries, LP – Northfield UDI-DI 2022-08-03 Class II Under Investigation by firm Potential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled device when pulling the catheter out of the artificial airway in the patient suctioning process 136,080 units

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