Curaplex

Curaplex IV Start Kit with Tegaderm, 8in Ext Set, 10ml Flush Syringe, Swab, 2x2 Gauze, LF Tourniquet

Registry build 21.09.26
1manufacturer
22catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code POQ
Manufacturer City Province Registered as Device types
Huzhou Junda Industry Co., Ltd. Anji Zhejiang Contract manufacturer 129

Record

Regulatory record for Curaplex
Listed by Bound Tree Medical, LLC, United States
FDA product code POQ
Device type Blood Transfusion Kit
Device class Class 2
Regulation 21 CFR 880.5440
Establishment Manufacturer
Premarket notification Exempt
Record published 2019-07-01
Record revised 2023-12-06 (version 8)

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 50, case of 20, case of 25, case of 40, case of 30, pack of 50
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Curaplex
Catalogue number Size Status
670183-KIT In distribution
1715-01837 In distribution
670104-KIT In distribution
680152-KIT In distribution
670135-KIT In distribution
680151-KIT In distribution
1715-01837 In distribution
36756 In distribution
1715-01827 In distribution
3310-14192 In distribution
670126-KIT In distribution
8600-0INTS0-1218 In distribution
670068-KIT In distribution
670060-KIT In distribution
1715-01827 In distribution
670061-KIT In distribution
680153-KIT In distribution
8600-VILADP-1434 In distribution
680150-KIT In distribution
670014-KIT In distribution
670004-KIT In distribution
1715-01837-DOD In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
NAR North American Rescue, LLC. 10
Valkyrie Ltowb Collection Set Safeguard US Operating, LLC 8
Valkyrie Ltowb Administration Set Safeguard US Operating, LLC 8
Fresh Whole Blood Transfusion Set Safeguard US Operating, LLC 6
Forward Synchronis Medical LLC 3
TMM-Fbtk-FTX (Tactical Medical Module-Field Blood Transfusion Kit-Exercise) Altitude Technologies Inc. 1
TMM-LTC (Tactical Medical Module – Low Titer Collection) Altitude Technologies Inc. 1
Mojo RFR First Responder Set Safeguard US Operating, LLC 1
Whole Blood Collection and Transfusion Kit Altitude Technologies Inc. 1
TMM-FBT-SOF (Tactical Medical Module – Field Blood Transfusion-Spec Ops Forces) Altitude Technologies Inc. 1
Project Lavoy Blood Kit Altitude Technologies Inc. 1
TMM-LTA (Tactical Medical Module-Low Titer Administration) Altitude Technologies Inc. 1

Showing 12 of 14. All products under Blood Transfusion 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