V-Set V2GSSR

GUDID 9350902000044

GO MEDICAL INDUSTRIES PTY. LTD.

Intravenous administration set

• Primary Device ID: 9350902000044
• NIH Device Record Key: c7840a3d-0a54-4e72-9110-78451f9e6d8d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Set
• Version Model Number: V2 GSS
• Catalog Number: V2GSSR
• Company DUNS: 757634266
• Company Name: GO MEDICAL INDUSTRIES PTY. 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09350902000013 [Primary]
GS1	9350902000020 [Package]; Contains: 09350902000013; Package: Inner carton [50 Units]; In Commercial Distribution
GS1	9350902000037 [Package]; Contains: 09350902000013; Package: Outer carton - GL [300 Units]; In Commercial Distribution
GS1	9350902000044 [Package]; Contains: 09350902000013; Package: Outer carton - HEE [600 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K900336

FDA Product Code

• FPA: Set, Administration, Intravascular

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: 2019-12-11
• Device Publish Date: 2016-09-24

On-Brand Devices [V-Set]

• 09350902000136: V3, 3-Valve, MRI
• 9350902000129: V-SET, V3 3-Value, Tearable Pouch
• 9350902000082: V3 GISS
• 9350902000044: V2 GSS