AccessGUDID - DEVICE: DF1-C6HV (04035479005221)

GUDID

Device Identifier (DI) Information

Brand Name: DF1-C6HV
Version or Model: 118718
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 118718
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479005221
Issuing Agency: GS1
Commercial Distribution End Date: August 27, 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?
36102	Pacing/defibrillation lead electrical adaptor	An implantable device designed to adapt the electrical connectors of an implanted pacemaker and/or defibrillator pacing lead to a non-compatible pacemaker or defibrillator (i.e., when they do not meet connection design). This device is implanted with the pacemaker or defibrillator system.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DTD	pacemaker lead Adaptor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980023	000

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 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7d4ab976-9d60-4490-8be1-96289d74caee
Public Version Date: August 30, 2021
Public Version Number: 5
DI Record Publish Date: August 25, 2014