Fem-Flex II Femoral Arterial Cannula FEMII012AT

GUDID 00690103031133

FEM-FLEX II Femoral Arterial Cannula

Edwards Lifesciences LLC

Cardiopulmonary bypass cannula, femoral

• Primary Device ID: 00690103031133
• NIH Device Record Key: 0b628284-65a2-4ecf-9b4d-589198d06ce4
• Commercial Distribution Discontinuation: 2016-11-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Fem-Flex II Femoral Arterial Cannula
• Version Model Number: FEMII012AT
• Catalog Number: FEMII012AT
• Company DUNS: 134139174
• Company Name: Edwards Lifesciences LLC
• 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(800)822-9637
• Email: tech_support@edwards.com
• Phone: +1(800)822-9637
• Email: tech_support@edwards.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00690103031133 [Primary]
GS1	50690103031138 [Package]; Package: Shipper [5 Units]; Discontinued: 2016-11-14; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140208

FDA Product Code

• DWF: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Fem-Flex II Femoral Arterial Cannula]

• 00690103168365: FEM-FLEX II Femoral Arterial Cannula
• 00690103168358: FEM-FLEX II Femoral Arterial Cannula
• 00690103168341: FEM-FLEX II Femoral Arterial Cannula
• 00690103031287: FEM-FLEX II Femoral Arterial Cannula
• 00690103031256: FEM-FLEX II Femoral Arterial Cannula
• 00690103031232: FEM-FLEX II Femoral Arterial Cannula
• 00690103031195: FEM-FLEX II Femoral Arterial Cannula
• 00690103031171: FEM-FLEX II Femoral Arterial Cannula
• 00690103031133: FEM-FLEX II Femoral Arterial Cannula
• 00690103031119: FEM-FLEX II Femoral Arterial Cannula
• 00690103031072: FEM-FLEX II Femoral Arterial Cannula
• 00690103031058: FEM-FLEX II Femoral Arterial Cannula
• 00690103031010: FEM-FLEX II Femoral Arterial Cannula
• 00690103030990: FEM-FLEX II Femoral Arterial Cannula