Adelante SafeSheath II AS10013B5

GUDID 10885672002319

Hemostatic Tear-away Introducer System with Infusion Side Port, 10F

Oscor Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10885672002319
• NIH Device Record Key: 316d338a-12ca-4934-89c7-10a9a5b633f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adelante SafeSheath II
• Version Model Number: AS10013B5
• Catalog Number: AS10013B5
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• Device Count: 5
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Needle Gauge: 18 Gauge
• Lumen/Inner Diameter: 3.3 Millimeter
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885672002312 [Unit of Use]
GS1	10885672002319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122084

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: 2017-11-16

On-Brand Devices [Adelante SafeSheath II]

• 10885672002432: Hemostatic Tear-away Introducer System with Infusion Side Port, 11F
• 10885672002425: Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F
• 10885672002418: Hemostatic Tear-away Introducer System with Infusion Side Port, 10F
• 10885672002401: Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
• 10885672002395: Hemostatic Tear-away Introducer System with Infusion Side Port, 8F
• 10885672002388: Hemostatic Tear-away Introducer System with Infusion Side Port, 7F
• 10885672002371: Hemostatic Tear-away Introducer System with Infusion Side Port, 6F
• 10885672002364: Hemostatic Tear-away Introducer System with Infusion Side Port, 12.5F
• 10885672002357: Hemostatic Tear-away Introducer System with Infusion Side Port, 12F
• 10885672002333: Hemostatic Tear-away Introducer System with Infusion Side Port, 11F
• 10885672002326: Hemostatic Tear-away Introducer System with Infusion Side Port, 10.5F
• 10885672002319: Hemostatic Tear-away Introducer System with Infusion Side Port, 10F
• 10885672002302: Hemostatic Tear-away Introducer System with Infusion Side Port, 9.5F
• 10885672002296: Hemostatic Tear-away Introducer System with Infusion Side Port, 9F
• 10885672002289: Hemostatic Tear-away Introducer System with Infusion Side Port, 8.5F
• 10885672002272: Hemostatic Tear-away Introducer System with Infusion Side Port, 8F
• 10885672002258: Hemostatic Tear-away Introducer System with Infusion Side Port, 7F
• 10885672002241: Hemostatic Tear-away Introducer System with Infusion Side Port, 6F