AccessGUDID - DEVICE: SWAN-GANZ PACING TD CATHETER (00690103197334)

GUDID

Device Identifier (DI) Information

Brand Name: SWAN-GANZ PACING TD CATHETER
Version or Model: D205F7
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D205F7
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103197334
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: SWAN-GANZ PACING TD CATHETER

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
35854	Temporary cardiac pacing balloon catheter	A sterile, flexible, balloon-tipped, tube designed to deliver temporary pacing stimuli to the heart; it may detect bioelectric signals from the heart. It is used in the atria and/or ventricles and has electrodes which are usually applied to the ventricles and connect to an external pacemaker that generates the electrical pacing impulses. It may be unipolar or bipolar and facilitate the display of electrocardiographic signals. It is used: 1) in an emergency during bradycardia or asystole until a pacemaker can be implanted to control the heart rate; 2) during and/or after surgery; or 3) during cardiac catheterization [e.g., electrophysiological (EP) examinations]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LDF	Electrode, Pacemaker, Temporary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Store in a cool, dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: External diameter: 7f (2.3 mm), Usable Length: 110 cm

Device Record Status

Public Device Record Key: ccbd5f9b-c851-4c45-92e5-7709f6dced27
Public Version Date: January 21, 2019
Public Version Number: 1
DI Record Publish Date: December 20, 2018