Schon

14F x 24cm Schon XL Silicone Double Lumen Catheter (Temporary Access)

Registry build 21.09.26
1manufacturer
4catalogue numbers in this listing

Who Else Makes It

Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code LFJ
Manufacturer City Province Registered as Device types
Turnxon Precision Co., Ltd. Dongguan Guangdong Contract manufacturer 17

Record

Regulatory record for Schon
Listed by AngioDynamics, Inc., United States
FDA product code LFJ
Device type Catheter, Subclavian
Device class Class 2
Regulation 21 CFR 876.5540
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2015-09-15
Record revised 2021-11-03 (version 4)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date
Storage Storage environment temperature up to 27 °C
Packaging Box of 5, box of 10
Sizes Length 12 to 24 cm; catheter gauge 14 Fr; needle gauge 18 G

Catalogue Numbers

Catalogue numbers for Schon
Catalogue number Size Status
10800703 Length 24 cm In distribution
10801703 Length 24 cm In distribution
10800702 Length 20 cm In distribution
10800704 Catheter Gauge 14 Fr In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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Brevia Short Term Dialysis Catheter Bard Access Systems, Inc. 4
Mahurkar Mozarc Medical US LLC 4
Argyle Mozarc Medical US LLC 4
Brevia Dialysis Catheter Kit Bard Access Systems, Inc. 4
Hemo-Cath® Silicone Medical Components Inc 3
Hemo-Cath®ij Medical Components Inc 2
Soft-Cell Dialysis Catheter Kit 12.5 F x 19 cm Bard Access Systems, Inc. 1

Showing 12 of 25. All products under Catheter, Subclavian

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