Curaplex

Curaplex Officer Down Advanced IFAK - Molle Coyote - Made In USA

Registry build 21.09.26
33manufacturers in China registered for this device type
36catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (18), Zhejiang (9), Guangdong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code KGZ
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Principle & Will Biotech (Pinghu) Co., Ltd. Pinghu Zhejiang Contract manufacturer 39
Ningbo Luke Medical Devices Co., Ltd. Yuyao Zhejiang Contract manufacturer 27
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Changzhou DSB Medical Co., Ltd. Changzhou Jiangsu Contract manufacturer 16
Alleva Medical (D.G.) Ltd Dongguan Guangdong Contract manufacturer 13
Boen Healthcare Co., Ltd. Suzhou Jiangsu Specification developer 263
Jiangsu NEW Pentastar Medical Products Co., Ltd. Changzhou Jiangsu Exporter 146
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Guangzhou Nuoning Medical Supplies Co., Ltd. Guangzhou Guangdong Contract manufacturer 62

Showing 12 of 33. All 33 manufacturers in China registered for Accessories, Catheter

Record

Regulatory record for Curaplex
Listed by Bound Tree Medical, LLC, United States
FDA product code KGZ
Device type Accessories, Catheter
Device class Class 1
Regulation 21 CFR 878.4200
Establishment Manufacturer
Premarket notification Exempt
Record published 2018-12-15
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 Contains natural rubber latex
Label carries lot or batch number, expiry date
Packaging Case of 20, case of 10, case of 50, case of 25
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number Size Status
8600-01326 In distribution
ATFSABTK In distribution
661524 In distribution
8600-01135 In distribution
662115 In distribution
670188-KIT In distribution
8600-01474 In distribution
SEEIFAKKIT In distribution
660448-QC In distribution
670142-KIT In distribution
8600-01304 In distribution
670018-KIT In distribution
661318 In distribution
670141-KIT In distribution
670008-KIT In distribution
670094-KIT In distribution
8600-ACSTWN-12110 In distribution
8600-01323 In distribution
670139-KIT In distribution
8600-01163 In distribution
660787-US In distribution
670039-KIT In distribution
8600-01300 In distribution
8600-01371 In distribution
8600-01305 In distribution
8600-01323 In distribution
8600-01233 In distribution
680122-KIT In distribution
8600-01167 In distribution
8600-01135 In distribution
18311 In distribution
8600-AFD-AS-KIT In distribution
36768 In distribution
670140-KIT In distribution
660787 In distribution
8600-01304 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MedDrain Armm, Inc. 77
Silicone Drainage Tube Fortune Medical Instrument Corp. 74
Typenex Wound Drainage Typenex Medical, LLC 56
Cook Cook Incorporated 49
Marina Medical Marina Medical Instruments, Inc. 48
Mediplus Mediplus Ltd. 29
AlliedSil™ Silicone Tubing Implantech Associates, Inc. 24
Arrow Teleflex Medical LLC 23
Silicone Thoracic Catheters Atrium Medical Corporation 21
Neff Cook Incorporated 18
Silhouette Cook Incorporated 16
Argyle Cardinal Health 16

Showing 12 of 111. All products under Accessories, Catheter

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