22MM FLEXTUBE SINGLE H/W LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB.>1.6M

GUDID 05030267161928

22MM FLEXTUBE SINGLE HEATED WIRE LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB. > 1.6M

Intersurgical Incorporated

Ventilator breathing circuit, single-use
Primary Device ID05030267161928
NIH Device Record Key95226754-1b99-4ea5-aee7-6ab0e67ed155
Commercial Distribution StatusIn Commercial Distribution
Brand Name22MM FLEXTUBE SINGLE H/W LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB.>1.6M
Version Model Number2060310
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
GS105030267161928 [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 Date2025-03-24
Device Publish Date2025-03-14

Devices Manufactured by Intersurgical Incorporated

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05030267045884 - 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M2025-04-24 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M
05030267001804 - TRACHEOSTOMY MASK, PAEDIATRIC2025-04-23 TRACHEOSTOMY MASK, PAEDIATRIC
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05030267165285 - 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE2025-04-23 22MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVEL ELBOW. 1.6M
00816472022552 - Nose Clip with Padding2025-04-22 Nose Clip with Padding
05030267161546 - 22mm Compact breathing system2025-04-22 22mm Compact breathing system with 3L bag, elbow, monitoring line, anesthetic face mask and HMEF >3m
05030267161751 - 22mm Compact breathing system2025-04-22 22mm Compact breathing system with 3L bag, monitoring line, HMEF, and Clearlite facemask >3 m

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