WINGMAN14 WGM14065US

GUDID 00856492005197

Wingman Crossing Catheter, 14X65cm

REFLOW MEDICAL, 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 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: 00856492005197
• NIH Device Record Key: ea81cb8a-0324-4878-ab21-bf52dcc1d0f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WINGMAN14
• Version Model Number: WGM14065US
• Catalog Number: WGM14065US
• Company DUNS: 962545294
• Company Name: REFLOW MEDICAL, 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: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com
• Phone: 949.481.0399
• Email: quality@reflowmedical.com

Device Dimensions

• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856492005197 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132420

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-09-23

On-Brand Devices [WINGMAN14]

• 00856492005197: Wingman Crossing Catheter, 14X65cm
• 00856492005159: Wingman Crossing Catheter, 14X135cm
• 00856492005142: Wingman Crossing Catheter, 14X150cm