Mixing Tips 153012

GUDID 00386040006166

Mixing Tips 12 x MIXING TIPS AQUA TYPE 2L NDS

Gc America Inc.

Pharmaceutical fluid-dispensing system

• Primary Device ID: 00386040006166
• NIH Device Record Key: 5f55c491-c861-4bcc-a9a5-9d058c1ef52a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mixing Tips
• Version Model Number: 153012
• Catalog Number: 153012
• Company DUNS: 005473608
• Company Name: Gc America Inc.
• Device Count: 12
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com
• Phone: +1(708)597-0900
• Email: customerservice@gcamerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00386040006166 [Unit of Use]
GS1	10386040006163 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K955932

FDA Product Code

• ELW: MATERIAL, IMPRESSION

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-15
• Device Publish Date: 2022-07-07

On-Brand Devices [Mixing Tips]

• 00386040006180: Mixing Tips 48 x MIXING TIPS INJECTION NDS PINK
• 00386040006173: Mixing Tips 48 x MIXING TIPS HEAVY NDS PURPLE
• 00386040006166: Mixing Tips 12 x MIXING TIPS AQUA TYPE 2L NDS
• 10386040006101: 100 INTRAORAL TIPS UNIVERSAL/NDS