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

GUDID 00850012625001

IMD AMSG3-E Kit

Angel Medical Systems, Inc.

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