CMS-9813

GUDID 50812496011072

EMPTY EVA CONTAINER With Detachable 3 Leg Transfer Set

METRIX COMPANY, THE

Intravenous administration bag/bottle

• Primary Device ID: 50812496011072
• NIH Device Record Key: c879c7af-0d87-418c-9a51-e5ff8b0fe8bd
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CMS-9813
• Catalog Number: CMS-9813
• Company DUNS: 043046283
• Company Name: METRIX COMPANY, THE
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004735414
• Email: customerservice@vygonus.com
• Phone: 8004735414
• Email: customerservice@vygonus.com

Device Dimensions

• Total Volume: 1000 Milliliter
• Total Volume: 1000 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00812496011077 [Primary]
GS1	50812496011072 [Package]; Contains: 00812496011077; Package: Cardboard Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030888

FDA Product Code

• KPE: Container, I.V.

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-24

Devices Manufactured by METRIX COMPANY, THE

• 50812496011560 - SECURE®: 2019-10-23 EMPTY EVA CONTAINER With 2 Ports
• 50812496011768 - SECURE®: 2019-10-23 EMPTY EVA CONTAINER With Male Screw Connector
• 50812496011287 - CORMIX: 2019-10-23 EMPTY EVA CONTAINER With Male Luer
• 50812496011294 - CORMIX: 2019-10-23 EMPTY EVA CONTAINER With Male Luer
• 50812496011478 - SECURE®: 2019-10-23 EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET (8 SETS OF 5 BAGS)
• 50812496011492 - SECURE®: 2019-10-23 EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET (8 SETS OF 5 BAGS)
• 50812496011515 - SECURE®: 2019-10-23 EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET (8 SETS OF 5 BAGS)
• 50812496011539 - SECURE®: 2019-10-23 EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET (8 SETS OF 5 BAGS)