ZOOM® Wireless Transmitter

GUDID 00802526562501

Wireless Transmitter

BOSTON SCIENTIFIC CORPORATION

Cardiac pulse generator programmer

• Primary Device ID: 00802526562501
• NIH Device Record Key: 7647a6a9-96c0-4d13-acfc-be5848bd7ddb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZOOM® Wireless Transmitter
• Version Model Number: 3140
• Company DUNS: 106295384
• Company Name: BOSTON SCIENTIFIC CORPORATION
• Device Count: 1
• 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	00802526562501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P910077

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

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• 00191506043193 - FARAWAVE™ NAV: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043209 - FARAWAVE™ NAV: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043216 - FARAWAVE™: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043223 - FARAWAVE™: 2024-10-30 Pulsed Field Ablation Catheter
• 00191506043698 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator
• 00191506043704 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator
• 00191506043711 - FARASTAR™: 2024-10-30 Pulsed Field Ablation Generator