22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 5191850

GUDID 05030267045952

22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE AND LIMB.1.6M

Intersurgical Incorporated

Ventilator breathing circuit, single-use
Primary Device ID05030267045952
NIH Device Record Key3072ec85-0e6f-4e02-bf05-ebe193056010
Commercial Distribution StatusIn Commercial Distribution
Brand Name22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE
Version Model Number5191850
Catalog Number5191850
Company DUNS785952607
Company NameIntersurgical Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+3154512900
Emailsupport@intersurgicalinc.com
Phone+3154512900
Emailsupport@intersurgicalinc.com
Phone+3154512900
Emailsupport@intersurgicalinc.com
Phone+3154512900
Emailsupport@intersurgicalinc.com
Phone+3154512900
Emailsupport@intersurgicalinc.com
Phone+3154512900
Emailsupport@intersurgicalinc.com
Phone+3154512900
Emailsupport@intersurgicalinc.com
Phone+3154512900
Emailsupport@intersurgicalinc.com
Phone+3154512900
Emailsupport@intersurgicalinc.com
Phone+3154512900
Emailsupport@intersurgicalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105030267045952 [Package]
Contains: 05030267069897
Package: [25 Units]
In Commercial Distribution
GS105030267069897 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-24
Device Publish Date2025-04-16

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