AngelMed Guardian EXD Model EXD-001 0203-2100-002#P16

GUDID 00850012625025

EXD-001 Kit

Angel Medical Systems, Inc.

Implantable cardiac monitor programmer/transmitter/alarm

• Primary Device ID: 00850012625025
• NIH Device Record Key: 20e2ceb5-10a6-4ce3-b7b1-7089f8a26c0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngelMed Guardian EXD Model EXD-001
• Version Model Number: 0203-2100-002#P16
• Catalog Number: 0203-2100-002#P16
• Company DUNS: 171391779
• Company Name: Angel Medical Systems, 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012625025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P150009

FDA Product Code

• QBI: Acute coronary syndrome event detector

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: 2021-03-05
• Device Publish Date: 2021-02-25

On-Brand Devices [AngelMed Guardian EXD Model EXD-001]

• 00850012625032: EXD-001 Kit (Latin-American Spanish)
• 00850012625025: EXD-001 Kit