Easy Pulse II Oxygen Conserver

GUDID 00855887006948

1900 SERIES,REG,02,EP5,870,GAUGE,OG

Precision Medical, Inc.

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• Primary Device ID: 00855887006948
• NIH Device Record Key: 3353c0db-7662-462c-86ba-9a450a62e7dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Pulse II Oxygen Conserver
• Version Model Number: 198705OG
• Company DUNS: 112569116
• Company Name: Precision Medical, 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: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• 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	00855887006948 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032018

FDA Product Code

• CAW: Generator, Oxygen, Portable

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: 2020-10-07
• Device Publish Date: 2020-09-29

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