Breezeway II® Delivery Sheath BG100079045

GUDID 00885672010683

DELIVERY SHEATH, 10F 79CM 45° SET

Oscor Inc.

Vascular guide-catheter, single-use

• Primary Device ID: 00885672010683
• NIH Device Record Key: fad642ec-be73-4e2f-a2eb-e94173debfea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breezeway II® Delivery Sheath
• Version Model Number: BG100079045
• Catalog Number: BG100079045
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• Device Count: 1
• 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: true
• 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
• 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

• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter
• Outer Diameter: 4.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 3.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672010683 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210627

FDA Product Code

• DYB: INTRODUCER, CATHETER

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-13
• Device Publish Date: 2021-09-03

On-Brand Devices [Breezeway II® Delivery Sheath]

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• 00885672010720: DELIVERY SHEATH, 11F 79CM 180° SET
• 00885672010713: DELIVERY SHEATH, 11F 79CM 45° SET
• 00885672010706: DELIVERY SHEATH, 10F 110CM 45° SET
• 00885672010690: DELIVERY SHEATH, 10F 79CM 180° SET
• 00885672010683: DELIVERY SHEATH, 10F 79CM 45° SET
• 00885672010676: DELIVERY SHEATH, 9F 110CM 45° SET
• 00885672010669: DELIVERY SHEATH, 9F 79CM 180° SET
• 00885672010652: DELIVERY SHEATH, 9F 79CM 45° SET
• 00885672010645: DELIVERY SHEATH, 8F 110CM 45° SET
• 00885672010638: DELIVERY SHEATH, 8F 79CM 180° SET
• 00885672010621: DELIVERY SHEATH, 8F 79CM 45° SET
• 00885672010614: DELIVERY SHEATH, 7F 110CM 45° SET
• 00885672010607: DELIVERY SHEATH, 7F 79CM 180° SET
• 00885672010591: DELIVERY SHEATH, 7F 79CM 45° SET
• 00885672010584: DELIVERY SHEATH, 6F 110CM 45° SET
• 00885672010577: DELIVERY SHEATH, 6F 79CM 180° SET
• 00885672010560: DELIVERY SHEATH, 6F 79CM 45° SET