AccessGUDID - DEVICE: Protego DF-1 (04035479151126)

GUDID

Device Identifier (DI) Information

Brand Name: Protego DF-1
Version or Model: S DX 65/17
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 414032
Company Name: BIOTRONIK SE & Co. KG

Primary DI Number: 04035479151126
Issuing Agency: GS1
Commercial Distribution End Date: October 05, 2022
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:	Yes
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?
35853	Endocardial defibrillation lead	An implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, intended to function as an electrical conductor to transmit defibrillation impulses from an implanted cardioverter-defibrillator (ICD) [automatic implantable cardioverter-defibrillator (AICD)] to the endocardium of the right ventricle. It may also be intended to transmit pacing impulses from a cardiac resynchronization therapy (CRT) pulse generator, AICD, or other pacing device. It is typically impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NVY	Permanent defibrillator electrodes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P980023	070

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
Special Storage Condition, Specify: Store at temperatures up to 77 deg F; excursions permitted from 41 deg F to 131 deg F
Storage Environment Temperature: less than 77 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Length: 65 cm
Device Size Text, specify: Distance tip-atrial dipole: 170 mm

Device Record Status

Public Device Record Key: 3449eb1c-62db-462c-82f3-0a8ace1340d2
Public Version Date: October 06, 2022
Public Version Number: 5
DI Record Publish Date: December 03, 2015