AccessGUDID - DEVICE: Fem-Flex II Femoral Arterial Cannula (00690103031133)

GUDID

Device Identifier (DI) Information

Brand Name: Fem-Flex II Femoral Arterial Cannula
Version or Model: FEMII012AT
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FEMII012AT
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103031133
Issuing Agency: GS1
Commercial Distribution End Date: November 14, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: FEM-FLEX II Femoral Arterial Cannula

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47733	Cardiopulmonary bypass cannula, femoral	A sterile, rigid or semi-rigid tube designed to be inserted into a femoral artery or vein during cardiopulmonary bypass procedures. It is typically a 9 to 24 Fr tube with an end hole (some may include side holes); it is short enough to keep the distal tip inside the femoral vessel. The tube is used in set-ups/systems intended to divert the patient's blood to and from external tubing and an arterial pump, bypassing the heart and lungs completely. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140208	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 12 Fr. (4.0 mm) x 6.5 cm (2.6")

Device Record Status

Public Device Record Key: 0b628284-65a2-4ecf-9b4d-589198d06ce4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 31, 2016