V-Set V3GISSR

GUDID 9350902000082

GO MEDICAL INDUSTRIES PTY. LTD.

Intravenous administration set

• Primary Device ID: 9350902000082
• NIH Device Record Key: 640caf43-828c-40e9-a2da-a2048bd1cb53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: V-Set
• Version Model Number: V3 GISS
• Catalog Number: V3GISSR
• 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	09350902000051 [Primary]
GS1	9350902000068 [Package]; Contains: 09350902000051; Package: Inner carton [50 Units]; In Commercial Distribution
GS1	9350902000075 [Package]; Contains: 09350902000051; Package: Outer carton - GL [300 Units]; In Commercial Distribution
GS1	9350902000082 [Package]; Contains: 09350902000051; 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