Disposable Hemodialysis Access Catheter Set Single

GUDID 26938634496273

Guangdong Baihe Medical Technology Co., Ltd.

Haemodialysis catheterization kit
Primary Device ID26938634496273
NIH Device Record Key1bde00bb-26af-4685-8d81-ed4b7401cf4f
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Hemodialysis Access Catheter Set Single
Version Model NumberH2Z-FH-1715
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
GS106938634496279 [Primary]
GS116938634496276 [Package]
Contains: 06938634496279
Package: [10 Units]
In Commercial Distribution
GS126938634496273 [Package]
Contains: 16938634496276
Package: [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MPBCatheter, Hemodialysis, Non-Implanted

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

On-Brand Devices [Disposable Hemodialysis Access Catheter Set Single]

26938634496303H2Z-FH-1816
26938634496297H2Z-FH-1815
26938634496280H2Z-FH-1814
26938634496273H2Z-FH-1715
26938634496266H2Z-FH-1714
26938634496259H2Z-FH-1713
26938634496242H2Z-FH-1712
26938634492862H2Z-FH-1813
26938634492855H2Z-FH-1716
26938634490387H2Z-FH-1812
26938634490370H2Z-FH-1811

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