PSW 464078

GUDID 04035479174798

BIOTRONIK SE & Co. KG

Cardiac pulse generator programmer

• Primary Device ID: 04035479174798
• NIH Device Record Key: 993637b0-8996-4a51-b5ac-7e60d8fd3088
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PSW
• Version Model Number: 2100.U
• Catalog Number: 464078
• Company DUNS: 315620229
• Company Name: BIOTRONIK SE & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com
• Phone: +1(888)345-0374
• Email: jon.brumbaugh@biotronik.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04035479174798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950037

FDA Product Code

• OSR: Pacemaker/icd/crt non-implanted components

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-12
• Device Publish Date: 2021-05-04

On-Brand Devices [PSW]

• 04035479166397: 1904.U
• 04035479157692: 1703.U
• 04035479157678: 1702.U
• 04035479154165: 1506.U/1
• 04035479152765: 1507.U
• 04035479150204: 1502.U
• 04035479149260: 1501.U
• 04035479147143: 1403.U
• 04035479140670: 1304.U
• 04035479140380: 1307.U
• 04035479151843: 1506.U
• 04035479150211: 1503.U
• 04035479174798: 2100.U
• 04035479160838: 1801.U
• 04035479157708: 1704.U
• 04035479162047: 1802.U
• 04035479164423: 1901.U
• 04035479164416: 1804.U
• 04035479178024: 2201.U/1
• 04035479181543: 2301.U
• 04035479179632: 2204.U
• 04035479184292: 2303.U
• 04035479186012: 2401.U