GUDID 20763000353401



Cardiopulmonary bypass system tubing set
Primary Device ID20763000353401
NIH Device Record Key847f5b60-9179-428d-ad81-1f3fa4b4b05f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNA
Version Model NumberCB11E58R1
Company DUNS006261481
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000353391 [Primary]
GS120763000353401 [Package]
Contains: 00763000353391
Package: PK [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWFCatheter, cannula and tubing, vascular, cardiopulmonary bypass


Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-10
Device Publish Date2020-02-01

On-Brand Devices [NA]

00613994951557CUSTOM PACK 1E53R7 3/8X1/4 E
00613994951311CUSTOM PACK CB6Y39R6 L SUPPORT
00613994951304CUSTOM PACK CB6Y43R1 INF SET
00613994951175EXTENSION 3708120 OCTAD 1X8 BLU WRNCH
00613994951168EXTENSION 3708140 OCTAD 1X8 BLU WRNCH
00613994951151EXTENSION 3708160 OCTAD 1X8 BLU WRNCH
00613994951144EXTSN 3708220 8-2-4 OCTAPOLAR BLU WRNCH
00613994951137EXTSN 3708240 8-2-4 OCTAPOLAR BLU WRNCH
00613994951120EXTSN 3708260 8-2-4 OCTAPOLAR BLU WRNCH
00613994951113EXTENSION 3708320 QUAD 8-4 BLU WRNCH
00613994951106EXTENSION 3708340 QUAD 8-4 BLU WRNCH
00613994951090EXTENSION 3708360 QUAD 8-4 BLU WRNCH
00613994951083EXT 748910 QUAD IN LINE LZ BLUE WRNCH
00613994951076EXT 748925 QUAD IN LINE LZ BLUE WRNCH
00613994951069EXT 748940 QUAD IN LINE LZ BLUE WRNCH
00613994951052EXT 748951 QUAD IN LINE LZ BLUE WRNCH
00613994951045EXT 748966 QUAD IN LINE LZ BLUE WRNCH
20613994946649CUSTOM PACK 4Z18R2 5PK GREEN LINE
20613994944256CATHETER 038467 PF 5PK 6F ANGIO KIT
20613994944232CATH 038465 PF 5PK KIT6F ST XT ANGIO-KIT
20613994944171CATHETER 038457 PF 5PK 6F ST ANGIO KIT
20613994943044CATHETER 038448 PF 5PK 6F XT ANGIO KIT
20613994942870CATH 008420 PF 6F SOFT TIP ANGIO-KIT 5PK
20613994942863CATHETER 008419 PF 6F ANGIO KIT 5PK
20613994942184CATH 014903 PF 5PK KIT 7F XT ANGIO KIT
20613994941965CATH 038445 PF 5PK KIT6F ST XT ANGIO KIT
20613994941958CATHETER 038443 PF 5PK 6F ST ANGIO-KIT
20613994941941CATHETER 038442 PF 5PK 6F ANGIO KIT
20613994941927CATHETER 038019 PF 5PK 6F BTO ANG KIT
20613994941828CATH 018418 PF 5PK KIT6F ST XT ANGIO KIT
20613994940401CATHETER 6B0007 SS 5PK 6F BTO CHOICE PK
20613994940326CATHETER 6A0137 SS 5PK 6F BTO ANG KIT
20613994940319CATH 6A0108 SS 6F ANG KIT W/3DRC 145 5PK
20613994940081CATH 6A0064 SS 5PK 6F ANG KITW/145 PGTL
20613994940074CATH 6A0063 SS 5PK 6F ANG KIT W/STRPGTL
00613994939845CATH 6A0103 SS 5PK6F ANG KITW/145 XT 6SH
20613994939832CATH 6A0102 SS 5PK6F ANG KIT W/STR XT6SH
20613994939719CATH 6A0072 SS 6F ANG KIT W/3DRC XT 5PK
20613994939672CATH 6A0065 SS 5PK 6F ANG KITW/155 PGTL
20613994939245CATH 218445 PF 5PK KIT6F ST XT CHOICE PK
20613994938361CATHETER 250026 SS 6F BTO-FLO XT CHPAK
00613994937889CUSTOM PACK CB6M32R2 NNTL ECMO
20613994937869CUSTOM PACK CB6Y77R 5PK NNTL RW
00613994937810STYLET KIT 609349 STR EXTD .016 PURPLE
00613994937803STYLET KIT 608249 STR EXTD .014 GRAY
20613994936329CATHETER 5B0013 SS 5PK 5F BTO ANG KIT
20613994936237CATH 5A0095 SS 5PK 5F ANG KIT W/3DRC 145
20613994936190CATH 5A0072 SS 5PK 5F ANG KIT W/3DRC STR
20613994936152CATH 5A0064 SS 5PK 5F ANG KIT W/155 PGTL

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