Spex LP

GUDID 10850025525029

speX LP Shapeable Support Catheter, 35 X 135cm, US

REFLOW MEDICAL, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 10850025525029
• NIH Device Record Key: 768357ef-66d9-47ce-b1db-486f0bc243fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spex LP
• Version Model Number: SLP35135US
• 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

Device Dimensions

• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch
• Catheter Working Length: 135 Centimeter
• Guidewire Diameter: 0.035 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850025525022 [Primary]
GS1	10850025525029 [Package]; Contains: 00850025525022; Package: [5 Units]; 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: 2021-06-18
• Device Publish Date: 2021-06-10

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