Curaplex

Curaplex AirQ3 Kit Size 3 with Suction Catheter (size 14) and Lube Jelly

Registry build 21.09.26
42manufacturers in China registered for this device type
27catalogue 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 Curaplex
Listed by Bound Tree Medical, LLC, United States
FDA product code CAF
Device type Nebulizer (Direct Patient Interface)
Device class Class 2
Regulation 21 CFR 868.5630
Establishment Manufacturer
Premarket notification Exempt
Record published 2017-12-12
Record revised 2022-08-16 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Latex Labelled latex-free
Label carries lot or batch number, expiry date, manufacturing date
Packaging Case of 50, pack of 50, case of 30, case of 35, case of 25
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number Size Status
301-8600-01267 In distribution
8600-AEMSKP-1486 In distribution
SEENEBK In distribution
301-0317D In distribution
661125 In distribution
30059 In distribution
N7281NICKIT In distribution
8600-01315 In distribution
30557 Adult In distribution
8600-01359 In distribution
30556 Pediatric In distribution
8600-01301 In distribution
8600-01270 In distribution
670137-KIT In distribution
36627 In distribution
301-670251-KIT In distribution
812-BVMNEBKIT In distribution
30556 Pediatric In distribution
30557 Adult In distribution
8600-01265 In distribution
661964 In distribution
8600-AEMSKA-1485 In distribution
8600-01302 In distribution
30055 Adult In distribution
301-0923A In distribution
301-8600-01266 In distribution
670260-KIT In distribution

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
Drivemedical Drive DeVilbiss Healthcare 40

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

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