Spex LP

GUDID 00856492005630

speX LP Shapeable Support Catheter, 14 X 90cm, US

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 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 Vascular guide-catheter, single-use

• Primary Device ID: 00856492005630
• NIH Device Record Key: bacc1ba0-f2db-4179-83b3-159b504f769c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spex LP
• Version Model Number: SLP14090US
• 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: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com
• Phone: 9494810399
• Email: quality@reflowmedical.com

Device Dimensions

• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 90 Centimeter
• Guidewire Diameter: 0.014 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856492005630 [Primary]
GS1	10856492005637 [Package]; Package: [5 Units]; In Commercial Distribution
GS1	10856492005668 [Package]; Package: [5 Units]; Discontinued: 2020-12-18; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200094

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2020-05-18
• Device Publish Date: 2020-05-08

On-Brand Devices [Spex LP]

• 00856492005685: speX LP Shapeable Support Catheter, 18 X 150cm, US
• 00856492005678: speX LP Shapeable Support Catheter, 18 X 135cm, US
• 00856492005661: speX LP Shapeable Support Catheter, 18 X 90cm, US
• 00856492005654: speX LP Shapeable Support Catheter, 14 X 150cm, US
• 00856492005647: speX LP Shapeable Support Catheter, 14 X 135cm, US
• 00856492005630: speX LP Shapeable Support Catheter, 14 X 90cm, US
• 10850025525036: speX LP Shapeable Support Catheter, 35 X 150cm, US
• 10850025525029: speX LP Shapeable Support Catheter, 35 X 135cm, US
• 00850025525015: speX LP Shapeable Support Catheter, 35 X 90cm, US