Passeo-35 389777

GUDID 07640130435759

Biotronik AG

Peripheral angioplasty balloon catheter, basic
Primary Device ID07640130435759
NIH Device Record Keyda15ad5a-71f1-4e46-a8b8-efd17b4a28e7
Commercial Distribution StatusIn Commercial Distribution
Brand NamePasseo-35
Version Model Number3/150/130
Catalog Number389777
Company DUNS480862817
Company NameBiotronik AG
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 Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)345-0374
Emailjon.brumbaugh@biotronik.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment TemperatureBetween 10 Degrees Celsius and 40 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight Store in a dry location

Device Identifiers

Device Issuing AgencyDevice ID
GS107640130435759 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, angioplasty, peripheral, transluminal

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 [Passeo-35]

076401304357663/170/130
076401304357593/150/130
076401304357423/170/90
076401304357353/150/90
076401304357043/200/130
076401304356983/200/90
076401304347457/200/130
076401304347386/200/130
076401304347215/200/130
076401304347144/200/130
076401304347077/170/130
076401304346916/170/130
076401304346845/170/130
076401304346774/170/130
076401304346607/150/130
076401304346536/150/130
076401304346465/150/130
076401304346394/150/130
076401304346227/120/130
076401304346156/120/130
076401304346085/120/130
076401304345924/120/130
076401304345853/120/130
076401304345544/100/130
076401304345473/100/130
0764013043453010/80/130
076401304345239/80/130
076401304345164/80/130
076401304345093/80/130
0764013043449310/60/130
076401304344869/60/130
076401304344794/60/130
076401304344623/60/130
0764013043445510/40/130
076401304344489/40/130
0764013043443110/20/130
076401304344249/20/130
076401304344177/200/90
076401304344006/200/90
076401304343945/200/90
076401304343874/200/90
076401304343707/170/90
076401304343636/170/90
076401304343565/170/90
076401304343494/170/90
076401304343327/150/90
076401304343256/150/90
076401304343185/150/90
076401304343014/150/90
076401304342957/120/90

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