AccessGUDID - DEVICE: Inventra 7 VR-T DX DF-1 ProMRI (04035479136314)

GUDID

Device Identifier (DI) Information

Brand Name: Inventra 7 VR-T DX DF-1 ProMRI
Version or Model: 399436
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 399436
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479136314
Issuing Agency: GS1
Commercial Distribution End Date: October 16, 2020
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?	MR Conditional
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?
35852	Single-chamber implantable defibrillator	An implantable pulse generator (IPG) with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), intended to deliver an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate, and typically to pace a slow heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected a lead(s) that are positioned inside or on one heart chamber (typically right ventricle) to monitor the ECG and to automatically deliver the electrical impulse. It has internal batteries that provide the energy for the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWS	Implantable cardioverter defibrillator (non-CRT)

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
Storage Environment Temperature: between 41 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 01cabb50-63f5-45d9-872c-650ab284b97e
Public Version Date: December 06, 2024
Public Version Number: 7
DI Record Publish Date: January 07, 2016