Blood Collection Needle With/without Holder, Safety Blood Collection Needle With/without Holder, Luer Access Device-holder With Preattached Multiple Sample Adapter

Tubes, Vials, Systems, Serum Separators, Blood Collection

Jiangsu Caina Medical Co., Ltd.

The following data is part of a premarket notification filed by Jiangsu Caina Medical Co., Ltd. with the FDA for Blood Collection Needle With/without Holder, Safety Blood Collection Needle With/without Holder, Luer Access Device-holder With Preattached Multiple Sample Adapter.

Pre-market Notification Details

Device IDK200027
510k NumberK200027
Device Name:Blood Collection Needle With/without Holder, Safety Blood Collection Needle With/without Holder, Luer Access Device-holder With Preattached Multiple Sample Adapter
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town Jiangyin,  CN 214415
ContactJianwei Pan
CorrespondentDiana Hong
Mid-Link Consulting Co. Ltd P.O Box 120-119 Shanghai,  CN 200120
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-06
Decision Date2020-09-09

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20193489103219 K200027 000
20197344041975 K200027 000
30193489189654 K200027 000
20850037100730 K200027 000
20850037100747 K200027 000
30885632401316 K200027 000
20885632401326 K200027 000
20885632401333 K200027 000
20885632401357 K200027 000
20885632401364 K200027 000
20197344039255 K200027 000

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