In-Line Gas Warmer

GUDID 00817183020233

In-Line gas warmer is for use with laparoscopic insufflators

NORTHGATE TECHNOLOGIES INC.

Insufflation gas conditioning system control unit

• Primary Device ID: 00817183020233
• NIH Device Record Key: 73fdeaa6-7b13-4a04-a41b-09fabf064f0e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In-Line Gas Warmer
• Version Model Number: 6-820-00
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817183020233 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992381

FDA Product Code

• HIF: Insufflator, Laparoscopic

Sterilization

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

[00817183020233]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00817183020233]

Ethylene Oxide;Moist Heat or Steam Sterilization

[00817183020233]

Ethylene Oxide;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-13

On-Brand Devices [In-Line Gas Warmer]

• 00817183020240: In-Line gas warmer is for use with laparoscopic insufflators
• 00817183020233: In-Line gas warmer is for use with laparoscopic insufflators
• 00817183020592: In-Line gas warmer is for use with laparoscopic insufflators