Connector, Barbed High Flow, Insufflation 72-00147-0

GUDID 00817183020653

NORTHGATE TECHNOLOGIES INC.

Endoscopic insufflation tubing set, single-use
Primary Device ID00817183020653
NIH Device Record Keyfd84b084-fb6f-40b1-b6c3-72111451693f
Commercial Distribution StatusIn Commercial Distribution
Brand NameConnector, Barbed High Flow, Insufflation
Version Model Number8055
Catalog Number72-00147-0
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
GS100817183020653 [Primary]
GS100885554016451 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HIFInsufflator, Laparoscopic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-17
Device Publish Date2020-08-07

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