N/A 72-00273-0

GUDID 00817183020714

CO2 Shuttle Valve System, Insufflation

NORTHGATE TECHNOLOGIES INC.

High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing High-pressure medical gas tubing
Primary Device ID00817183020714
NIH Device Record Key7ac7042e-da71-49ee-b668-28b29a98bddd
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model Number72203995
Catalog Number72-00273-0
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 Batchtrue
Serial Numberfalse
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
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100817183020714 [Primary]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]
GS100885554032338 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic
HIFInsufflator, Laparoscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

On-Brand Devices [N/A]

00817183020738CO2 Hose and Yoke, Insufflation
00817183020721CO2 Hose and DISS, Insufflation
00817183020714CO2 Shuttle Valve System, Insufflation
00817183020707Insufflation Tubing, General Use CPC

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