In-Line Gas Warmer 7209944

GUDID 00817183020592

In-Line gas warmer is for use with laparoscopic insufflators

NORTHGATE TECHNOLOGIES INC.

Insufflation gas conditioning system control unit

• Primary Device ID: 00817183020592
• NIH Device Record Key: 9218d734-1171-4c27-b134-e247045c4110
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: In-Line Gas Warmer
• Version Model Number: 72-00204-0
• Catalog Number: 7209944
• 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	00817183020592 [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

[00817183020592]

Moist Heat or Steam Sterilization;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-02-22

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