AccessGUDID - DEVICE: Etrinsa 8 HF-T (04035479131777)

GUDID

Device Identifier (DI) Information

Brand Name: Etrinsa 8 HF-T
Version or Model: 394919
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 394919
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479131777
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?
47263	Cardiac resynchronization therapy implantable pacemaker	A battery-powered, hermetically-sealed pulse generator, intended to be implanted beneath the skin of the chest in a surgically-created pocket, and used with pacing leads placed in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber) to stimulate the heart to beat at a faster rate when it senses bradycardia and provides cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions to treat symptoms of heart failure (e.g., easy fatigue) and serious heart-rhythm problems [CRT pacemaker (CRT-P)]; it is not intended for defibrillation therapy.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NKE	Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

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: 6461deb7-3767-4b9b-b5ba-dbbf7507fd1a
Public Version Date: August 25, 2021
Public Version Number: 5
DI Record Publish Date: December 09, 2014