Olive

GUDID 06976653490007

Zhengzhou Olive Electronic Technology Co., Ltd.

Mobile/portable oxygen concentrator

• Primary Device ID: 06976653490007
• NIH Device Record Key: 84eef481-42c6-4137-8413-59bb7f93f281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olive
• Version Model Number: OLV-10S
• Company DUNS: 560081443
• Company Name: Zhengzhou Olive Electronic Technology Co., Ltd.
• 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: true
• 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	06976653490007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222920

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: 2023-09-11
• Device Publish Date: 2023-09-01

On-Brand Devices [Olive]

• 06976653490014: OLV-5S
• 06976653490007: OLV-10S