AngelMed Guardian Programmer Application User's Manual CD 0204-2100-073#P16

GUDID 00850012625131

PROG-003 Application User's Manual CD

Angel Medical Systems, Inc.

Implantable cardiac device management application software

• Primary Device ID: 00850012625131
• NIH Device Record Key: 2715c78b-d856-4290-aba4-af73eeae506a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AngelMed Guardian Programmer Application User's Manual CD
• Version Model Number: 0204-2100-073#P16
• Catalog Number: 0204-2100-073#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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	00850012625131 [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