DALTON OXYGEN CONCENTRATOR

GUDID 00815027012376

OXYGEN CONCENTRATOR 5 LITER.

DALTON MEDICAL CORPORATION

Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator

• Primary Device ID: 00815027012376
• NIH Device Record Key: 2cabb532-6149-4f71-ae8e-ed94e8b25760
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DALTON OXYGEN CONCENTRATOR
• Version Model Number: R-DOC5100
• 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	00815027012376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090007

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: 2021-06-24
• Device Publish Date: 2021-06-16

On-Brand Devices [DALTON OXYGEN CONCENTRATOR]

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