DALTON OXYGEN CONCENTRATOR

GUDID 00815027012512

OXYGEN CONCENTRATOR 5 LITER.

DALTON MEDICAL CORPORATION

Stationary oxygen concentrator

• Primary Device ID: 00815027012512
• NIH Device Record Key: a27de8f3-8f24-47fd-b310-52d55a9ebc71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DALTON OXYGEN CONCENTRATOR
• Version Model Number: R-DOC5200
• Company DUNS: 874709348
• Company Name: DALTON MEDICAL CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815027012512 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191875

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: 2023-03-30
• Device Publish Date: 2023-03-22

On-Brand Devices [DALTON OXYGEN CONCENTRATOR]

• 00815027012376: OXYGEN CONCENTRATOR 5 LITER.
• 00815027012512: OXYGEN CONCENTRATOR 5 LITER.