Breezeway II® Plus Delivery Sheath BG120079045L

GUDID 00885672010546

DELIVERY SHEATH PLUS, 12F 79CM 45° LKIT

Oscor Inc.

Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use Vascular guide-catheter, single-use

• Primary Device ID: 00885672010546
• NIH Device Record Key: ceeca15e-529c-4208-abc5-04662d7e3c95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Breezeway II® Plus Delivery Sheath
• Version Model Number: BG120079045L
• Catalog Number: BG120079045L
• 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: true
• 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

• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 4.1 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 5 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672010546 [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® Plus Delivery Sheath]

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• 00885672010546: DELIVERY SHEATH PLUS, 12F 79CM 45° LKIT
• 00885672010539: DELIVERY SHEATH PLUS, 11F 79CM 180° LKIT
• 00885672010522: DELIVERY SHEATH PLUS, 11F 79CM 45° LKIT
• 00885672010515: DELIVERY SHEATH PLUS, 10F 110CM 45° LKIT
• 00885672010508: DELIVERY SHEATH PLUS, 10F 79CM 180° LKIT
• 00885672010492: DELIVERY SHEATH PLUS, 10F 79CM 45° LKIT
• 00885672010485: DELIVERY SHEATH PLUS, 9F 110CM 45° LKIT
• 00885672010478: DELIVERY SHEATH PLUS, 9F 79CM 180° LKIT
• 00885672010461: DELIVERY SHEATH PLUS, 9F 79CM 45° LKIT
• 00885672010454: DELIVERY SHEATH PLUS, 8F 110CM 45° LKIT
• 00885672010447: DELIVERY SHEATH PLUS, 8F 79CM 180° LKIT
• 00885672010430: DELIVERY SHEATH PLUS, 8F 79CM 45° LKIT
• 00885672010423: DELIVERY SHEATH PLUS, 7F 110CM 45° LKIT
• 00885672010416: DELIVERY SHEATH PLUS, 7F 79CM 180° LKIT
• 00885672010409: DELIVERY SHEATH PLUS, 7F 79CM 45° LKIT
• 00885672010393: DELIVERY SHEATH PLUS, 6F 110CM 45° LKIT
• 00885672010386: DELIVERY SHEATH PLUS, 6F 79CM 180° LKIT
• 00885672010379: DELIVERY SHEATH PLUS, 6F 79CM 45° LKIT