Curaplex

Curaplex Cricothyrotomy Kit, Adult, w/Gloves, Swab, Scalpel, 4x4 Gauze, Syringe, and Tape

Registry build 21.09.26
1manufacturer
23catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code OGP
Manufacturer City Province Registered as Device types
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46

Record

Regulatory record for Curaplex
Listed by Bound Tree Medical, LLC, United States
FDA product code OGP
Device type Cricothyrotomy Kit
Device class Class 2
Regulation 21 CFR 868.5800
Establishment Manufacturer
Premarket notification Exempt
Record published 2019-12-30
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 10, case of 30, case of 25, case of 50, case of 40, case of 20
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number Size Status
351632I-A In distribution
8600-01288 In distribution
8600-01291 In distribution
8600-01290 In distribution
36611 In distribution
1011 In distribution
SEECRIC In distribution
13301 In distribution
351631-A In distribution
8600-01285 In distribution
1014 In distribution
18315 In distribution
670136-KIT In distribution
13302 In distribution
660383 In distribution
8600-01340 In distribution
1013 In distribution
661565 In distribution
8600-01486 In distribution
36612 In distribution
660487 In distribution
351631I-A In distribution
680121-KIT In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Motion Medical Distributing Haslam Medical, Inc. 25
NAR North American Rescue, LLC. 13
Tactical CricKIT North American Rescue, LLC. 9
Cardinal Health Cardinal Health 200, LLC 8
NAR Kit North American Rescue, LLC. 5
Forward Synchronis Medical LLC 2
Endotracheal Kit NAR Medical Depot, LLC 2
H&H Emergency Cricothyrotomy Kit H & H Co. 1
TMM-CR-SO (Tactical Medical Module – Cricothyroidotomy Special Operations) Altitude Technologies Inc. 1
Emergency Cric Kit Safeguard US Operating, LLC 1
ReadyCric Kit H & H Co. 1
TMM-BCR-Tactical Medical Module Bougie Assisted Cricothyrotomy Altitude Technologies Inc. 1

Showing 12 of 22. All products under Cricothyrotomy Kit

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