VALITUDE™ CRT-P

GUDID 00802526559389

Cardiac Resynchronization Therapy Pacemaker

BOSTON SCIENTIFIC CORPORATION

Cardiac resynchronization therapy implantable pacemaker

• Primary Device ID: 00802526559389
• NIH Device Record Key: 448c07b8-5e2a-4db6-8244-8853859da974
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VALITUDE™ CRT-P
• Version Model Number: U125
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526559389 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P030005

FDA Product Code

• NKE: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2014-11-11

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

• 00802526618208 - myLUX™ Patient App: 2025-04-21 For Insertable Cardiac Monitor
• 00802526618215 - myLUX™ Patient App: 2025-04-21 for Insertable Cardiac Monitor
• 00191506046330 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046347 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046354 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046361 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046378 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter
• 00191506046385 - Sterling™: 2025-03-31 PTA Balloon Dilatation Catheter