Able Central Venous Catheter Triple Lumen 5.5F*15c

GUDID 26938634492688

Guangdong Baihe Medical Technology Co., Ltd.

Central venous catheter
Primary Device ID26938634492688
NIH Device Record Key39ffeddc-d097-4477-b775-6e2966fcf0e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameAble Central Venous Catheter Triple Lumen 5.5F*15c
Version Model Number02X-FV-352915
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
GS106938634492684 [Primary]
GS116938634492681 [Package]
Contains: 06938634492684
Package: [10 Units]
In Commercial Distribution
GS126938634492688 [Package]
Contains: 16938634492681
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 Date2016-09-22

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

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