Pre-filled Syringe With Saline

Saline, Vascular Access Flush

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 Pre-filled Syringe With Saline.

Pre-market Notification Details

Device IDK220060
510k NumberK220060
Device Name:Pre-filled Syringe With Saline
ClassificationSaline, Vascular Access Flush
Applicant Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Rd, Zhutang Town Jiangyin,  CN 214415
ContactJianwei Pan
CorrespondentDiana Hong
Mid-Link Consulting Co.,Ltd P.O Box 120-119 Shanghai,  CN 200120
Product CodeNGT  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-10
Decision Date2022-06-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00369771003437 K220060 000
20612479273157 K220060 000
20612479273188 K220060 000
10386120013098 K220060 000
00840117334489 K220060 000
08401173345264 K220060 000
10850049248065 K220060 000
00811220035143 K220060 000
00811220035174 K220060 000
00811220035099 K220060 000
00811220035112 K220060 000
00840117334533 K220060 000

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