AccessGUDID - DEVICE: Integrity® (05414734006781)

GUDID

Device Identifier (DI) Information

Brand Name: Integrity®
Version or Model: ADx SR
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5160
Company Name: ST. JUDE MEDICAL, INC.

Primary DI Number: 05414734006781
Issuing Agency: GS1
Commercial Distribution End Date: February 13, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 790268031 *Terms of Use

Device Description: Pulse Generator SSIR

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

GMDN Preferred Term Name	GMDN Definition
Single-chamber implantable pacemaker, rate-responsive	A sterile, battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended to provide defibrillation therapy.

GMDN Preferred Term Name

GMDN Definition

Single-chamber implantable pacemaker, rate-responsive

A sterile, battery-powered device consisting of a hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with a pacing lead in or on one chamber of the heart (right atrium or ventricle). It is intended to generate and conduct electrical impulses to an abnormal heart to adjust its rate of contraction to meet the body's increased need for blood flow due to activity. It contains one or more sensors to detect changes in the body (e.g., motion, breathing frequency) to indicate more oxygen is needed, and subsequently increases the pacing rate; it is not intended to provide defibrillation therapy.

FDA Product Code

[?]

Product Code	Product Code Name
KRG	Programmer, pacemaker

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P880086	094

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
Handling Environment Temperature: between 23 and 122 Degrees Fahrenheit
Storage Environment Temperature: between 23 and 122 Degrees Fahrenheit
Storage Environment Temperature: between -5 and 50 Degrees Celsius
Handling Environment Temperature: between -5 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 7.9 Milliliter

Device Record Status

Public Device Record Key: 62281d8a-b01d-45c7-b7db-dedd62996e72
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 25, 2014