SaniGuard

Non-injectable Catheter Cap

Registry build 21.09.26
5manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (3), Zhejiang (1), Jiangxi (1).

Chinese manufacturers registered for FDA product code FJK
Manufacturer City Province Registered as Device types
Ningbo Tianyi Medical Appliance Co., Ltd. Ningbo Zhejiang Contract manufacturer 11
Guangzhou Kaiheng K&S Co., Ltd. Guangzhou Guangdong Contract manufacturer 9
Jiangxi Sanxin Medtec Co., Ltd. Nanchang Jiangxi Manufacturer 6
Bain Medical Equipment(Guangzhou) Co., Ltd. Guangzhou Guangdong Manufacturer 3
Vital Healthcare (Guangzhou) Co., Ltd. Guangzhou Guangdong Contract manufacturer 3

Record

Regulatory record for SaniGuard
Listed by Reprocessing Products Corp, United States
FDA product code FJK
Device type Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Device class Class 2
Regulation 21 CFR 876.5820
510(k) K852605
Record published 2017-01-19
Record revised 2020-09-09 (version 5)

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
Packaging Package of 2000, package of 100

Catalogue Numbers

Catalogue numbers for SaniGuard
Catalogue number Size Status
7001-3915 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
ICU Medical ICU Medical, Inc 58
Nipro SET Blood Tubing SET With Transducer Protectors AND Priming SET Nipro Medical Corporation 12
Hemodialysis Bloodlines B. Braun Medical Inc. 12
CombiSet Fresenius Medical Care 11
Cartridge Blood Set Gambro Renal Products S.A. DE C.V. 8
5008X Fresenius Medical Care Renal Therapies Group, LLC 7
Sunder Sunder Biomedical Tech. Co., Ltd. 6
Streamline Airless System Set with Locksite Needleless Access Sites Medisystems Corp. 5
Tablo(R) Cartridge Outset Medical, Inc. 5
NovaLine Bain Medical Equipment(Guangzhou) Co., Ltd. 5
Medisystems Hemodialysis Blood Tubing Sets Medisystems Corp. 4
Diapact® B. Braun Medical Inc. 4

Showing 12 of 44. All products under Set, Tubing, Blood, With And Without Anti-Regurgitation Valve

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