NEBULAE SRS Tubing Set

GUDID 00817183020660

NORTHGATE TECHNOLOGIES INC.

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• Primary Device ID: 00817183020660
• NIH Device Record Key: 9fd3c729-90b1-4d12-8e1f-87616423251d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEBULAE SRS Tubing Set
• Version Model Number: 7-510-57
• 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	00817183020660 [Primary]
GS1	10817183020667 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202944

FDA Product Code

• FYD: Apparatus, Exhaust, Surgical

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: 2023-02-22
• Device Publish Date: 2023-02-14

Devices Manufactured by NORTHGATE TECHNOLOGIES INC.

• 00817183020776 - StimSite Activation Card: 2023-11-29 Activation Card, StimSite, Single
• 00817183020660 - NEBULAE SRS Tubing Set: 2023-02-22
• 00817183020660 - NEBULAE SRS Tubing Set: 2023-02-22
• 00817183020684 - NEBULAE SRS Laparoscopic Surgical Pump: 2023-02-22
• 00817183020745 - Smith & Nephew Insufflator 500: 2021-01-14 Insufflator, Laparoscopic, S&N 500 Service Replacement, 50LPM
• 10817183020605 - TAP: 2021-01-13 Insufflation Tubing, True Abdominal Pressure Sensing
• 00817183020707 - N/A: 2021-01-13 Insufflation Tubing, General Use CPC
• 00817183020714 - N/A: 2021-01-13 CO2 Shuttle Valve System, Insufflation
• 00817183020721 - N/A: 2021-01-13 CO2 Hose and DISS, Insufflation