Able Central Venous Catheter Triple Lumen 5.5F*10c

GUDID 26938634490318

Guangdong Baihe Medical Technology Co., Ltd.

Central venous catheter
Primary Device ID26938634490318
NIH Device Record Keybcb76bd7-0298-4cd6-b129-e5af4bd038f3
Commercial Distribution StatusIn Commercial Distribution
Brand NameAble Central Venous Catheter Triple Lumen 5.5F*10c
Version Model Number02X-FV-3523
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
GS106938634490314 [Primary]
GS116938634490311 [Package]
Contains: 06938634490314
Package: [10 Units]
In Commercial Distribution
GS126938634490318 [Package]
Contains: 16938634490311
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.

26938634454303 - Disposable Hemodialysis Access Catheter Set 2024-06-19
26938634454426 - Disposable Hemodialysis Access Catheter Set 2024-06-19
26938634460175 - ABLE CENTRAL VENOUS CATHETER2024-06-19
26938634461851 - ABLE CENTRAL VENOUS CATHETER2024-06-19
26938634463039 - ABLE CENTRAL VENOUS CATHETER2024-06-19
26938634463190 - ABLE CENTRAL VENOUS CATHETER2024-06-19
26938634476817 - ABLE CENTRAL VENOUS CATHETER2024-06-19
26938634477357 - ABLE CENTRAL VENOUS CATHETER2024-06-19

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