SPEX35 SPX35090US

GUDID 00856492005128

Spex Shapeable Support Catheter, 35X90cm

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: 00856492005128
• NIH Device Record Key: 3e231067-7487-4ba4-8f62-0df979f765cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPEX35
• Version Model Number: SPX35090US
• Catalog Number: SPX35090US
• 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: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856492005128 [Primary]

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: 6
• Public Version Date: 2019-10-30
• Device Publish Date: 2016-09-23

On-Brand Devices [SPEX35]

• 00856492005135: Spex Shapeable Support Catheter, 35X50cm
• 00856492005128: Spex Shapeable Support Catheter, 35X90cm
• 00856492005111: Spex Shapeable Support Catheter, 35X135cm
• 00856492005104: Spex Shapeable Support Catheter, 35X150cm
• 00850025525091: Spex Shapeable Support Catheter, 35 X 150cm, US
• 00850025525084: Spex Shapeable Support Catheter, 35 X 135cm, US
• 00850025525077: Spex Shapeable Support Catheter, 35 X 90cm, US
• 00850025525060: Spex Shapeable Support Catheter, 35 X 50cm, US