EMBLEM™ S-ICD Programmer

GUDID 00802526610516

EMBLEM S-ICD Programmer

BOSTON SCIENTIFIC CORPORATION

Cardiac pulse generator programmer

• Primary Device ID: 00802526610516
• NIH Device Record Key: 5711bd55-174e-4212-83c8-a8926a78dee5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMBLEM™ S-ICD Programmer
• Version Model Number: 3200
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00802526610516 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P110042

FDA Product Code

• LWS: Implantable cardioverter defibrillator (non-CRT)

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: 2019-11-14
• Device Publish Date: 2019-11-06

On-Brand Devices [EMBLEM™ S-ICD Programmer]

• 00802526605345: EMBLEM S-ICD Programmer
• 00802526586507: EMBLEM S-ICD Programmer
• 00802526580604: EMBLEM S-ICD Programmer
• 00802526609206: EMBLEM S-ICD Programmer
• 00802526610516: EMBLEM S-ICD Programmer
• 00802526615108: Programmer