AngelMed Guardian IMD Model AMSG3-E 0212-2100-001#P16

GUDID 00850012625001

IMD AMSG3-E Kit

Angel Medical Systems, Inc.

Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor Implantable cardiac monitor

• Primary Device ID: 00850012625001
• NIH Device Record Key: 97eddb46-2673-4d5a-a924-f945c231d2cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngelMed Guardian IMD Model AMSG3-E
• Version Model Number: 0212-2100-001#P16
• Catalog Number: 0212-2100-001#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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850012625001 [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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-03-11
• Device Publish Date: 2021-03-03

Devices Manufactured by Angel Medical Systems, Inc.

• 00850012625001 - AngelMed Guardian IMD Model AMSG3-E: 2021-03-11IMD AMSG3-E Kit
• 00850012625001 - AngelMed Guardian IMD Model AMSG3-E: 2021-03-11 IMD AMSG3-E Kit
• 00850012625018 - AngelMed Guardian Torque Wrench: 2021-03-05 Hex Torque Wrench (Separate, in Sterile Pack)
• 00850012625025 - AngelMed Guardian EXD Model EXD-001: 2021-03-05 EXD-001 Kit
• 00850012625032 - AngelMed Guardian EXD Model EXD-001: 2021-03-05 EXD-001 Kit (Latin-American Spanish)
• 00850012625049 - AngelMed Guardian EXD Carrying Case: 2021-03-05 EXD Carrying Case
• 00850012625056 - AngelMed Guardian EXD Lanyard: 2021-03-05 EXD Lanyard
• 00850012625063 - AngelMed Guardian Programmer Model PROG-003: 2021-03-05 PROG-003 Kit (US)
• 00850012625070 - AngelMed Guardian Programmer Wand EXD Model EXD-001: 2021-03-05 PROG-003 Wand