Intensia

GUDID 08031527012810

MICROPORT CRM SRL

Cardiac resynchronization therapy implantable defibrillator

• Primary Device ID: 08031527012810
• NIH Device Record Key: 3b6ddf55-db54-47ea-b9be-abbf642d9538
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Intensia
• Version Model Number: CRT-D 174
• Company DUNS: 438860859
• Company Name: MICROPORT CRM SRL
• 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: 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	08031527012810 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060027

FDA Product Code

• NIK: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)

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: 2020-10-20
• Device Publish Date: 2015-02-20

On-Brand Devices [Intensia]

• 08031527012834: VR 124
• 08031527012827: DR 154
• 08031527012810: CRT-D 174