3B Medical, Inc.'s Cirrus 5

GUDID 00853041003703

Stationary 5 lpm oxygen concentrator

3B MEDICAL, INC.

Stationary oxygen concentrator

• Primary Device ID: 00853041003703
• NIH Device Record Key: bfc4d697-9956-4865-8e56-a39b028b5087
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3B Medical, Inc.'s Cirrus 5
• Version Model Number: CIR1005
• Company DUNS: 078517316
• Company Name: 3B 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	00853041003703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131968

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-18