22MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6M

GUDID 05030267097913

22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. > 1.6M

Intersurgical Incorporated

Ventilator breathing circuit, single-use
Primary Device ID05030267097913
NIH Device Record Key08021c43-3c9a-4bfc-9279-eb1bba64121c
Commercial Distribution StatusIn Commercial Distribution
Brand Name22MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6M
Version Model Number2026310
Company DUNS785952607
Company NameIntersurgical Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
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
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
GS105030267060719 [Primary]
GS105030267097913 [Package]
Contains: 05030267060719
Package: [7 Units]
In Commercial Distribution

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 Date2025-03-24
Device Publish Date2025-03-14

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