BS IS-1

Basic Information

• Brand Name: BS IS-1
• Primary DI: 04035479144791
• Version / Model: 330834
• Catalog Number: 330834
• Company Name: BIOTRONIK SE & Co. KG
• Labeler DUNS: 315620229
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-04
• Public Version: 5
• Public Version Date: 2021-03-19
• Public Version Status: Update
• Public Device Record Key: dcd47251-910f-47bd-ac67-b3ae127268d6

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: MR Conditional
• 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
DXY	implantable pacemaker Pulse-generator	Cardiovascular	870.3610	3

GMDN Terms

Code	Name	Definition	Implantable	Status
44900	Implantable pulse generator port plug	A non-active implantable device designed for insertion into the vacant/unused connector port of an implantable pulse generator (e.g., cardiac pacemaker/defibrillator, neurostimulator) to seal and electrically isolate the port, and to protect the parent device. It is typically made of metal and/or polymer materials.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04035479038403	GS1	case	10	In Commercial Distribution
Primary	04035479144791	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P950037	022
P980023	082

Storage Conditions

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