Drivemedical

RespiratorySuction Product Description: Carrying Case for Ped Suct MQ1200 1/ea

Registry build 21.09.26
42manufacturers in China registered for this device type
40catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (23), Jiangsu (7), Fujian (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code CAF
Manufacturer City Province Registered as Device types
Flexicare Medical (Dongguan) Ltd. Dongguan Guangdong Contract manufacturer 48
Sunmed AP, Ltd. Zhuhai Guangdong Contract manufacturer 18
Polymed (Xiamen) Plastic Industrial Co., Ltd. Xiamen Fujian Contract manufacturer 17
Sunmed AP, Ltd., Warehouse NO. 2 Zhuhai Guangdong Contract manufacturer 16
Hangzhou Jinlin Medical Appliances Co., Ltd. Hangzhou Zhejiang Contract manufacturer 11
Shenzhen Huayan E-Commerce Co., Ltd. Shenzhen Guangdong Contract manufacturer 11
Shenzhen BI-Rich Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9
Respironics Medical Products (Shenzhen) Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Omron (Dalian) Co., Ltd. (Plant 1) Dalian Liaoning Contract manufacturer 7
Apex Medical (Kunshan) Corp. Kunshan Jiangsu Contract manufacturer 4
Dongguan Polygreen Technology Co., Ltd. Dongguan Guangdong Contract manufacturer 4
Living Science Co., Ltd. Suzhou Jiangsu Contract manufacturer 3

Showing 12 of 42. All 42 manufacturers in China registered for Nebulizer (Direct Patient Interface)

Record

Regulatory record for Drivemedical
Listed by Drive DeVilbiss Healthcare, United States
FDA product code CAF
Device type Nebulizer (Direct Patient Interface)
Device class Class 2
Regulation 21 CFR 868.5630
Establishment Repacker / relabeller
510(k) K052811
Record published 2016-09-16
Record revised 2025-09-24 (version 9)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries lot or batch number, serial number
Packaging Pack of 6, pack of 8, pack of 12, pack of 25, master carton of 8
Distribution end date 2024-08-19

Catalogue Numbers

Catalogue numbers for Drivemedical
Catalogue number Size Status
MQ6002R In distribution
18071 In distribution
MQ6005R In distribution
4055IMEDS In distribution
4057IMEDS In distribution
MQ6003R In distribution
4060IMEDS In distribution
18082 In distribution
PB42367R In distribution
18091-FS In distribution
4059IMEDS In distribution
4058IMEDS In distribution
18090-FS In distribution
3050-3NDS In distribution
3050-2NDS In distribution
18080 In distribution
18040-P Withdrawn
MQ-COOK02 Withdrawn
MQ-COOK03 Withdrawn
18081-IHO Withdrawn
18081-OXYLIFE Withdrawn
18080P Withdrawn
18081-OXYLIFE2 Withdrawn
MQ-ARH Withdrawn
MQ5700-JLMED Withdrawn
MQ-FLETCHERS Withdrawn
3050-2 Withdrawn
MQ-MSA Withdrawn
18070-KOH Withdrawn
3050-2-BMR.NEB3 Withdrawn
18081-AMS Withdrawn
3050-2NDS-PURCH Withdrawn
MQ5800-PETSCH Withdrawn
MQ1200C Withdrawn
18091FS-IHO Withdrawn
18090BE-AFL Withdrawn
18081-ROBERTS Withdrawn
18090FS-AFL Withdrawn
6910D-607 Withdrawn
18040-Y Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Hudson RCI Teleflex Medical LLC 220
AirLife Carefusion 77
AirLife™ Airlife, Inc. 76
Ventlab Ventlab, LLC 56
I-neb Respironics Respiratory Drug Delivery (Uk), Ltd. 55
Aerogen® Solo Nebulizer System Aerogen Ltd 53
Portex ICU Medical, Inc 50
Sidestream Respironics Respiratory Drug Delivery (Uk), Ltd. 48
Hudson RCI Medline Industries, Inc. 46
DeVilbiss DeVilbiss Healthcare LLC. 45
Drive Drive DeVilbiss Healthcare 42
Medline Medline Industries, Inc. 38

Showing 12 of 541. All products under Nebulizer (Direct Patient Interface)

Recalls Naming This Product

1 recall names this product by its own identifier, the 510(k) it is cleared under.

Recalls naming the identifiers of Drivemedical
Recalled by Identified by Initiated FDA class Root cause Reason Quantity Closed
Compass Health Brands (Distribution Center) 510(k) number 2015-04-20 Class II Use error Roscoe Medical has recently identified the need to update its user manual with additional warning statements regarding proper handling and storage of the nebulizer. These warnings are to better inform end users of proper care when using and 219,353 Manuals 2016-10-25

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