Disposable Hemodialysis Access Catheter Set Double

GUDID 26938634491803

Guangdong Baihe Medical Technology Co., Ltd.

Haemodialysis catheterization kit
Primary Device ID26938634491803
NIH Device Record Key215b08c7-0d37-47ff-854e-ba1200f83649
Commercial Distribution StatusIn Commercial Distribution
Brand NameDisposable Hemodialysis Access Catheter Set Double
Version Model NumberR2W-FR-2914
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
GS106938634491809 [Primary]
GS116938634491806 [Package]
Contains: 06938634491809
Package: [10 Units]
In Commercial Distribution
GS126938634491803 [Package]
Contains: 16938634491806
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 Double]

26938634496402R2Z-FR-241924
26938634496396R2W-FR-2416
26938634496389R2Z-FR-2416
26938634496372R2W-FR-2415
26938634496365R2Z-FR-2415
26938634496358R2W-FR-241915
26938634496341R2Z-FR-241915
26938634496334R2W-FR-2614
26938634496327R2W-FR-2613
26938634496310R2W-FR-2612
26938634493012R2W-FR-2915
26938634493005R2W-FR-291915
26938634492992R2Z-FR-291915
26938634492978R2W-FR-2912
26938634492961R2W-FR-2615
26938634492954R2Z-FR-2615
26938634492886R2W-FR-211915
26938634492879H2Z-FH-211915
26938634491827R2Z-FR-2912
26938634491810R2Y-FR-2915
26938634491803R2W-FR-2914
26938634491797R2Y-FR-2914
26938634491780R2Z-FR-2612
26938634491773R2Z-FR-2613
26938634491766R2Y-FR-2614
26938634491759G2W-FR-2216
26938634491742G2Z-FR-2216
26938634491735G2W-FR-2215
26938634491728G2Z-FR-2215
26938634491711G2Z-FR-2214
26938634491704R2W-FR-2116
26938634491698R2Z-FR-2116
26938634491681H2W-FH-2115
26938634491674H2Y-FH-2125
26938634491667R2W-FR-2114
26938634491650H2Z-FH-2114
26938634491643H2Z-FH-2116
26938634491636H1W-FH-2115
26938634491629H1Z-FH-2115
26938634491612H2W-FH-2114
26938634491605H2Y-FH-2114
26938634491094R5W-FR-2255
26938634491087R5Z-FR-2255
26938634491070G6W-FR-2256
26938634491063G6Z-FR-2256
26938634490547R6W-FR-225915
26938634490530R6Z-FR-225915
26938634490523G6W-FR-2254
26938634490516G6Z-FR-2254
26938634490509H5W-FH-2155

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