ECO Range - Maxi Series

GUDID 35019315083215

GVS Technology (Suzhou) Co., Ltd.

Heat/moisture exchanger, single-use

• Primary Device ID: 35019315083215
• NIH Device Record Key: 0e8ce09e-643c-46a4-9309-00a49ff5a350
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ECO Range - Maxi Series
• Version Model Number: 62.002.0070.4333/710CRSA
• Company DUNS: 420798347
• Company Name: GVS Technology (Suzhou) 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: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15019315083211 [Primary]
GS1	35019315083215 [Package]; Contains: 15019315083211; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033008

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

On-Brand Devices [ECO Range - Maxi Series]

• 35019315083291: 62.002.0079.4244/711CRSA
• 35019315083222: 62.002.0135.4333/751BRSA
• 35019315083215: 62.002.0070.4333/710CRSA
• 35019315082980: 62.002.0131.4333/750BRSA