Valve Bypass Tool A85VBT03B25

GUDID 30836559009536

Valve Bypass Tool, 8.5F

Oscor Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 30836559009536
• NIH Device Record Key: 3dc7061e-b2eb-413a-b17e-3a6280b7e9b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Valve Bypass Tool
• Version Model Number: A85VBT03B25
• Catalog Number: A85VBT03B25
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• Device Count: 25
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com
• Phone: +1(727)937-2511
• Email: sales@oscor.com

Device Dimensions

• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter
• Lumen/Inner Diameter: 3 Millimeter
• Length: 3 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00836559009535 [Unit of Use]
GS1	30836559009536 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073100

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2017-11-15

On-Brand Devices [Valve Bypass Tool]

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