Coda® GELT-230

GUDID 00815965021072

Coda Eco 1200 - 230V

LIFEGLOBAL GROUP, LLC

Non-respiratory device ambient air filter

• Primary Device ID: 00815965021072
• NIH Device Record Key: e8fc97c3-ee65-46c2-80e9-c3ef12b7fae4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coda®
• Version Model Number: GELT-230
• Catalog Number: GELT-230
• Company DUNS: 141732011
• Company Name: LIFEGLOBAL GROUP, LLC
• 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

Customer Support Contacts

• Phone: +1(800)720-6375
• Email: Sales@LifeGlobal.com
• Phone: +1(800)720-6375
• Email: Sales@LifeGlobal.com
• Phone: +1(800)720-6375
• Email: Sales@LifeGlobal.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815965021072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001486

FDA Product Code

• MQG: ACCESSORY, ASSISTED REPRODUCTION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2016-09-21

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