Mariner

GUDID 15051684016230

Mariner Angiographic Catheter, Sidewinder (2), Braided

ANGIODYNAMICS, INC.

Angiographic catheter, single-use

• Primary Device ID: 15051684016230
• NIH Device Record Key: fac2b3e0-c365-4153-a1be-98d8aebb1a1e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner
• Version Model Number: 11710511
• Company DUNS: 079105071
• Company Name: ANGIODYNAMICS, 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: 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(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French
• Length: 65 Centimeter
• Outer Diameter: 1.8 Millimeter
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684016230 [Secondary]
HIBCC	H787117092420 [Primary]
HIBCC	H787117092425 [Package]; Contains: H787117092420; Package: Box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173762

FDA Product Code

• DQO: CATHETER, INTRAVASCULAR, DIAGNOSTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-15
• Device Publish Date: 2019-04-29

On-Brand Devices [Mariner]

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• 15051684016360: Mariner Angiographic Catheter, Omega, Braided
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• 15051684016346: Mariner Angiographic Catheter, Sharp Angle, Braided
• 15051684016339: Mariner Angiographic Catheter, Sharp Angle, Braided
• 15051684016322: Mariner Angiographic Catheter, Sharp Angle, Non-Braided
• 15051684016315: Mariner Angiographic Catheter, Omega, Braided
• 15051684016308: Mariner Angiographic Catheter, Sharp Angle, Non-Braided
• 15051684016452: Mariner Hydrophilic Coated Angiographic Catheter, ARC, Non-Braided
• 15051684016445: Mariner Hydrophilic Coated Angiographic Catheter, ARC, Braided
• 15051684016438: Mariner Hydrophilic Coated Angiographic Catheter, ARC, Non-Braided
• 15051684016421: Mariner Hydrophilic Coated Angiographic Catheter, ARC, Non-Braided
• 15051684016414: Mariner Hydrophilic Coated Angiographic Catheter, ARC, Braided
• 15051684016292: Mariner Angiographic Catheter, Sidewinder 1 ST, Non-Braided
• 15051684016285: Mariner Angiographic Catheter, Vertebral, Non-Braided
• 15051684016278: Mariner Angiographic Catheter, Vertebral, Braided
• 15051684016261: Mariner Angiographic Catheter, Vertebral, Braided
• 15051684016254: Mariner Angiographic Catheter, Vertebral, Non-Braided
• 15051684016247: Mariner Angiographic Catheter, Vertebral, Non-Braided
• 15051684016230: Mariner Angiographic Catheter, Sidewinder (2), Braided
• 15051684016223: Mariner Angiographic Catheter, Sidewinder 1 ST, Non Braided
• 15051684016216: Mariner Angiographic Catheter, Straight Art, Braided
• 15051684016209: Mariner Angiographic Catheter, Straight Art, Non-Braided
• 15051684016193: Mariner Angiographic Catheter, Straight Art, Braided
• 15051684016186: Mariner Angiographic Catheter, Sos Omni Selective (3), Non-Braided
• 15051684016179: Mariner Angiographic Catheter, Sos Omni Selective (3), Non-Braided
• 15051684016162: Mariner Angiographic Catheter, Sos Omni Selective (1), Non-Braided
• 15051684016155: Mariner Angiographic Catheter, Berenstein, Non-Braided
• 15051684016148: Mariner Angiographic Catheter, Berenstein, Non-Braided
• 15051684016131: Mariner Angiographic Catheter, Mani, Non-Braided
• 15051684016117: Mariner Angiographic Catheter, Headhunter (1), Braided
• 15051684016100: Mariner Angiographic Catheter, Headhunter (1), Non-Braided
• 15051684016407: Mariner Angiographic Catheter, Bentson (1), Non-Braided
• 15051684016124: Mariner Angiographic Catheter, JB (2), Braided
• 15051684016391: Mariner Angiographic Catheter, Berenstein, Non-Braided
• H787117086025: Mariner Hydrophilic Coated Angiographic Catheter, Straight flush, Non-Braided
• H787117072015: Mariner Hydrophilic Coated Angiographic Catheter, Straight flush, Non-Braided
• H787517071405: Mariner Hydrophilic Coated Angiographic Catheter, Omni Flush, Non-Braided
• H787517071355: Mariner Hydrophilic Coated Angiographic Catheter, Straight, Non-Braided
• H787517071335: Mariner Hydrophilic Coated Angiographic Catheter, Berenstein Braided
• H787517071275: Mariner Hydrophilic Coated Angiographic Catheter, Sos Omni Selective (1), Braided
• H787517071265: Mariner Hydrophilic Coated Angiographic Catheter, Berenstein, Braided
• H787517071255: Mariner Hydrophilic Coated Angiographic Catheter, Berenstein, Braided
• H787517071215: Mariner Hydrophilic Coated Angiographic Catheter, MPA, Non-Braided
• H787517071165: Mariner Hydrophilic Coated Angiographic Catheter, Simons Sidewinder (1), Non-Braided
• H787517071155: Mariner Hydrophilic Coated Angiographic Catheter, Berenstein, Braided
• H787517071145: Mariner Hydrophilic Coated Angiographic Catheter, Berenstein, Braided
• H787517071095: Mariner Hydrophilic Coated Angiographic Catheter, Rim, Non-Braided
• H787517071085: Mariner Hydrophilic Coated Angiographic Catheter, Rim, Non-Braided