Blood pressure cuff

GUDID 06946725526842

APK Technology Co.,Ltd.

Blood pressure cuff, reusable
Primary Device ID06946725526842
NIH Device Record Key5b3282a0-cdee-44c3-99af-70f9656d58f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameBlood pressure cuff
Version Model NumberA-XT-12W(1)
Company DUNS529691989
Company NameAPK Technology 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 Numberfalse
Manufacturing Datefalse
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
GS106946725526842 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-22
Device Publish Date2018-05-28

On-Brand Devices [Blood pressure cuff]

06946725527009A-XT-12D(5)
06946725526996A-XT-12D(4)
06946725526989A-XT-12D(3)
06946725526972A-XT-12D(2)
06946725526965A-XT-12D(1)
06946725526958A-XT-11D(13)
06946725526941A-XT-10D(12)
06946725526934A-XT-08D(9)
06946725526927A-XT-08D(7)
06946725526910A-XT-08D(10)
06946725526903A-XT-07D(11)
06946725526897A-XT-12W(7)
06946725526880A-XT-12W(5)
06946725526873A-XT-12W(4)
06946725526866A-XT-12W(3)
06946725526859A-XT-12W(2)
06946725526842A-XT-12W(1)
06946725526835A-XT-11W(13)
06946725526828A-XT-10W(12)
06946725526811A-XT-09W(8)
06946725526804A-XT-08W(9)
06946725526798A-XT-08W(10)
06946725526781A-XT-07W(11)
06946725526774A-XT-12
06946725526767A-XT-11
06946725526750A-XT-10
06946725526743A-XT-09
06946725526736A-XT-08
06946725526729A-XT-07
06946725523629A-XT-06D(13)
06946725523612A-XT-05D(12)
06946725523605A-XT-04D(7)
06946725523599A-XT-04D(5)
06946725523582A-XT-04D(4)
06946725523575A-XT-04D(3)
06946725523568A-XT-04D(2)
06946725523551A-XT-04D(1)
06946725523544A-XT-03D(8)
06946725523537A-XT-03D(9)
06946725523520A-XT-02D(10)
06946725523513A-XT-01D(11)
06946725523506A-XT-06W(13)
06946725523490A-XT-05W(12)
06946725523483A-XT-04W(7)
06946725523476A-XT-04W(5)
06946725523469A-XT-04W(4)
06946725523452A-XT-04W(3)
06946725523445A-XT-04W(2)
06946725523438A-XT-04W(1)
06946725523421A-XT-03W(8)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.