Able Central Venous Catheter Double Lumen 8F*13cm

GUDID 26938634490271

Guangdong Baihe Medical Technology Co., Ltd.

Central venous catheter
Primary Device ID26938634490271
NIH Device Record Key2b7f33e8-3cb0-4ce4-856b-be2bdcde76ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameAble Central Venous Catheter Double Lumen 8F*13cm
Version Model Number02L-FV-2824
Company DUNS547055364
Company NameGuangdong Baihe Medical 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106938634490277 [Primary]
GS116938634490274 [Package]
Contains: 06938634490277
Package: [10 Units]
In Commercial Distribution
GS126938634490271 [Package]
Contains: 06938634490277
Package: [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FOZCatheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

Devices Manufactured by Guangdong Baihe Medical Technology Co., Ltd.

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