Coda® GCIF-001

GUDID 00815965021560

Coda Filters for Coda Incubator Units - Single

LIFEGLOBAL GROUP, LLC

Non-respiratory device ambient air filter

• Primary Device ID: 00815965021560
• NIH Device Record Key: e09b399d-2e0e-44f8-ad8a-3164e0936576
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coda®
• Version Model Number: GCIF-001
• Catalog Number: GCIF-001
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815965020976 [Primary]
GS1	00815965021553 [Package]; Package: 12-pack, GCIF-012 [12 Units]; In Commercial Distribution
GS1	00815965021560 [Package]; Contains: 00815965020976; Package: 6-pack, GCIF-006 [6 Units]; In Commercial Distribution

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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• 00815965021720: Coda Lo-Boy Quarterly kit, 1st, 2nd, 3rd Stage
• 00815965021713: Coda Lo-Boy Initial/Annual Filter kit,4 Stage Filter System
• 00815965021706: Coda Tower Quarterly Filter kit, 1st, 2nd, 3rd Stage
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• 00815965021409: Choice A:CodaAir 900 Semi-Annual Shirtbox Filter(Single)
• 00815965021836: Coda Aero 700/800 Semi-Annual Filter (Single)
• 00815965021249: Coda 2 SP incubator Unit
• 00815965021218: Coda Aero 500 230V. Initial filter included.
• 00815965021201: Coda Aero 500 115V. Initial filter included.
• 00815965021577: Coda Aero 400/500 Quarterly Filter (single)
• 00815965021188: CodaAir 900, 24V universal adapter
• 00815965021171: CodaAir 800, 24V universal adapter
• 00815965021164: Coda Aero 700 230V. Initial filter included.
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• 00815965021072: Coda Eco 1200 - 230V
• 00815965021065: Coda Eco 1200 - 115V
• 00815965021058: Coda Eco 1500 - 230V
• 00815965021041: Coda Eco 1500 - 115V
• 00815965021010: CodaAir Positive Pressure Unit - 230V
• 00815965021003: CodaAir Positive Pressure Unit - 115V
• 00815965020990: Coda SP Incubator Unit
• 00815965020983: Coda Incubator Unit
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