BK-IS

Basic Information

• Brand Name: BK-IS
• Primary DI: 04035479144753
• Version / Model: 109185
• Catalog Number: 109185
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-22
• Public Version: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 24b25c7c-6aec-4c77-bd02-b37a16d2acdf

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTD	pacemaker lead Adaptor	Cardiovascular	870.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46221	Pacing/defibrillation lead cap	An implantable device designed to cover and protect the lead terminals of an implantable pacing device (e.g., an implanted pacemaker or defibrillator) during the implantation procedure, or to isolate (cap) any lead terminals that are not used. This device is implanted with the pacemaker or defibrillator system.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04035479000950	GS1	case	10	In Commercial Distribution
Primary	04035479144753	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K970204	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 41 – 131 Degrees Fahrenheit