AccessGUDID - DEVICE: Steelex (04038653926190)

GUDID

Device Identifier (DI) Information

Brand Name: Steelex
Version or Model: G0992100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: G0992100
Company Name: B BRAUN SURGICAL SA

Primary DI Number: 04038653926190
Issuing Agency: GS1
Commercial Distribution End Date: May 17, 2017
Device Count: 12
Labeler D-U-N-S® Number*: 511268005 *Terms of Use

Device Description: STEELEX ELEC 0 (3.5) 60CM HR26/GS65V

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Temporary cardiac pacing catheter	A sterile, flexible 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 which generates the electrical pacing impulses. It may be unipolar or bipolar and facilitates the display of the electrocardiographic signal. 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.

GMDN Preferred Term Name

GMDN Definition

Temporary cardiac pacing catheter

A sterile, flexible 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 which generates the electrical pacing impulses. It may be unipolar or bipolar and facilitates the display of the electrocardiographic signal. 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.

FDA Product Code

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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

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Storage and Handling
Storage Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf3faa92-d5a0-44c0-af23-13120d85020d
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 20, 2015