K152468

GUDID 96973521874184

Reusable NIBP cuff,Thigh,single tube, HP connector

Shenzhen Vistar Medical Supplies Co.,Ltd.

Blood pressure cuff, reusable
Primary Device ID96973521874184
NIH Device Record Key0f512d91-d058-47f8-a6a6-d2a2cf7895a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameK152468
Version Model NumberV0116C-HP
Company DUNS544328369
Company NameShenzhen Vistar Medical Supplies Co.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS196973521874184 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXQBlood Pressure Cuff

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-17
Device Publish Date2020-08-07

Devices Manufactured by Shenzhen Vistar Medical Supplies Co.,Ltd.

96973521872753 - N/A2023-06-20 STERILE DISPOSABLE TOURNIQUET CUFF,SINGLE PORT, SINGLE BLADDER, SIZE M, 24 IN
96973521872777 - N/A2023-06-20 STERILE DISPOSABLE TOURNIQUET CUFF,SINGLE PORT, SINGLE BLADDER, SIZE L, 34 IN
96973521872272 - N/A2023-06-08 STERILE DISPOSABLE TOURNIQUET CUFF,DUAL PORT, SINGLE BLADDER, 8 IN
96973521872289 - N/A2023-06-08 STERILE DISPOSABLE TOURNIQUET CUFF,DUAL PORT, SINGLE BLADDER, 12 IN
96973521872296 - N/A2023-06-08 STERILE DISPOSABLE TOURNIQUET CUFF,DUAL PORT, SINGLE BLADDER, 15 IN
96973521872302 - N/A2023-06-08 STERILE DISPOSABLE TOURNIQUET CUFF,DUAL PORT, SINGLE BLADDER, 18 IN
96973521872319 - N/A2023-06-08 STERILE DISPOSABLE TOURNIQUET CUFF,DUAL PORT, SINGLE BLADDER, 24 IN
96973521872326 - N/A2023-06-08 STERILE DISPOSABLE TOURNIQUET CUFF,DUAL PORT, SINGLE BLADDER, 30 IN

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