N/A 72-00160-0

GUDID 00817183020707

Insufflation Tubing, General Use CPC

NORTHGATE TECHNOLOGIES INC.

Endoscopic insufflation tubing set, single-use

• Primary Device ID: 00817183020707
• NIH Device Record Key: 95086dd1-cfc7-4d83-acf5-9be1a3a1862e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: 7205861
• Catalog Number: 72-00160-0
• Company DUNS: 627969264
• Company Name: NORTHGATE TECHNOLOGIES INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817183020707 [Primary]
GS1	10817183020704 [Package]; Package: PK [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914403

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-01-13
• Device Publish Date: 2021-01-05

On-Brand Devices [N/A]

• 00817183020738: CO2 Hose and Yoke, Insufflation
• 00817183020721: CO2 Hose and DISS, Insufflation
• 00817183020714: CO2 Shuttle Valve System, Insufflation
• 00817183020707: Insufflation Tubing, General Use CPC