In-Line Gas Warmer

GUDID 00817183020240

In-Line gas warmer is for use with laparoscopic insufflators

NORTHGATE TECHNOLOGIES INC.

Insufflation gas conditioning system control unit
Primary Device ID00817183020240
NIH Device Record Keybf3958fb-fc44-4b9a-97de-8e2b337c8b5b
Commercial Distribution StatusIn Commercial Distribution
Brand NameIn-Line Gas Warmer
Version Model Number6-810-00
Company DUNS627969264
Company NameNORTHGATE TECHNOLOGIES INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817183020240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIFInsufflator, Laparoscopic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00817183020240]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00817183020240]

Moist Heat or Steam Sterilization;Ethylene Oxide


[00817183020240]

Moist Heat or Steam Sterilization;Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-10-14

On-Brand Devices [In-Line Gas Warmer]

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

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