AccessGUDID - DEVICE: Epyra 6 DR-T (04035479131838)

GUDID

Device Identifier (DI) Information

Brand Name: Epyra 6 DR-T
Version or Model: 394932
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 394932
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479131838
Issuing Agency: GS1
Commercial Distribution End Date: August 24, 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:	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?
47265	Dual-chamber implantable pacemaker, rate-responsive	A battery-powered, hermetically-sealed pulse generator, implanted beneath the skin of the chest in a surgically-created pocket, with pacing leads in or on two chambers of the heart (right atrium and ventricle). It is intended to stimulate the chambers of an abnormal heart, through electrical impulses, to beat in their natural sequence, and to adjust the 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 for defibrillation therapy.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NVZ	Pulse generator, permanent, implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P950037	137

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
Storage Environment Temperature: between 14 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 965ecabe-5988-4939-8527-705336a57384
Public Version Date: August 25, 2021
Public Version Number: 5
DI Record Publish Date: December 09, 2014