BIS/BLV-13 BIS/BLV-13

GUDID 00836559004752

Oscor Inc.

Pacing/defibrillation lead electrical adaptor

• Primary Device ID: 00836559004752
• NIH Device Record Key: 5fbc5704-8776-4284-a684-7734a73cae69
• Commercial Distribution Discontinuation: 2018-05-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: BIS/BLV-13
• Version Model Number: BIS/BLV-13
• Catalog Number: BIS/BLV-13
• Company DUNS: 101835833
• Company Name: Oscor Inc.
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	00836559004752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K925168

FDA Product Code

• DTD: Pacemaker Lead Adaptor

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-11-10

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