V-Set V3GISSR

GUDID 9350902000082

GO MEDICAL INDUSTRIES PTY. LTD.

Intravenous administration set Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive Basic intravenous administration set, noninvasive

• 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