PUREPNEUMO Tubing Set

GUDID 10817183020810

Paired Insufflation and TAP Tubing

NORTHGATE TECHNOLOGIES INC.

Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use Endoscopic insufflation tubing set, single-use

• Primary Device ID: 10817183020810
• NIH Device Record Key: 3297a755-08c8-491f-bdea-253c0fa1fe66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PUREPNEUMO Tubing Set
• Version Model Number: 7-650-01
• Company DUNS: 627969264
• Company Name: NORTHGATE TECHNOLOGIES INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	00817183020813 [Primary]
GS1	10817183020810 [Package]; Contains: 00817183020813; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• NKC: Tubing/Tubing With Filter, Insufflation, 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: 2024-07-17
• Device Publish Date: 2024-07-09

Devices Manufactured by NORTHGATE TECHNOLOGIES INC.

• 10817183020810 - PUREPNEUMO Tubing Set: 2024-07-17Paired Insufflation and TAP Tubing
• 10817183020810 - PUREPNEUMO Tubing Set: 2024-07-17 Paired Insufflation and TAP Tubing
• 00817183020769 - StimSite Signal Box: 2024-05-07
• 00817183020776 - StimSite Activation Card: 2023-11-29 Activation Card, StimSite, Single
• 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