AccessGUDID - DEVICE: Model 3145 (04035479143190)

GUDID

Device Identifier (DI) Information

Brand Name: Model 3145
Version or Model: Refurbishment II
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 391500
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479143190
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 315620229 *Terms of Use

Device Description: No description.

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:	No
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?
36106	Implantable pacemaker analyser, intraoperative	An electronic instrument designed to test an implanted cardiac pacemaker, including the lead/tissue interface at the time of implantation, for invasive pacemaker evaluation and/or during electrophysiology (EP) diagnostic procedures. It has testing and recording capabilities to measure the minimum electrical stimulus needed to elicit ventricular contraction and the minimum intracardiac signal amplitude needed to inhibit the pacemaker (i.e., stimulation and sensing thresholds respectively). It typically includes measuring devices for the bioelectrical signals, a pulse generator, controllers, and the capability to test the characteristics and performance of the implanted pacemaker.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OVJ	Pulse generator, external pacemaker, dual-chamber

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950037	088

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Storage Environment Atmospheric Pressure 7-15 psi
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 25 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ea94c610-74c7-48ea-adfb-94a946beb7c8
Public Version Date: October 01, 2021
Public Version Number: 6
DI Record Publish Date: August 21, 2014