Valve Bypass Tool A10VBT03B25

GUDID 30836559009567

Valve Bypass Tool, 10F

Oscor Inc.

Vascular catheter introduction set, nonimplantable
Primary Device ID30836559009567
NIH Device Record Keya737409b-84dd-457b-a825-1d7d8c544b7c
Commercial Distribution StatusIn Commercial Distribution
Brand NameValve Bypass Tool
Version Model NumberA10VBT03B25
Catalog NumberA10VBT03B25
Company DUNS101835833
Company NameOscor Inc.
Device Count25
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(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com
Phone+1(727)937-2511
Emailsales@oscor.com

Device Dimensions

Lumen/Inner Diameter3.5 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter
Length3 Centimeter
Lumen/Inner Diameter3.5 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100836559009566 [Unit of Use]
GS130836559009567 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2017-11-15

On-Brand Devices [Valve Bypass Tool]

30885672006649Valve Bypass Tool, 9F
30885672006625Valve Bypass Tool, 8F
30885672006618Valve Bypass Tool, 7.5F
30885672006601Valve Bypass Tool, 7F
30885672006595Valve Bypass Tool, 6F
30836559009611Valve Bypass Tool, 12.5F
30836559009604Valve Bypass Tool, 12F
30836559009581Valve Bypass Tool, 11F
30836559009574Valve Bypass Tool, 10.5F
30836559009567Valve Bypass Tool, 10F
30836559009550Valve Bypass Tool, 9.5F
30836559009543Valve Bypass Tool, 9F
30836559009536Valve Bypass Tool, 8.5F
30836559009529Valve Bypass Tool, 8F
30836559009512Valve Bypass Tool, 7.5F
30836559009505Valve Bypass Tool, 7F
30836559009499Valve Bypass Tool, 6F

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