22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6M

GUDID 05030267040865

22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6M

Intersurgical Incorporated

Ventilator breathing circuit, reusable
Primary Device ID05030267040865
NIH Device Record Key22d45a44-1ee9-4e29-ac84-339c802a9e16
Commercial Distribution StatusIn Commercial Distribution
Brand Name22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6M
Version Model Number5113018
Company DUNS785952607
Company NameIntersurgical Incorporated
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
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

Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105030267040865 [Package]
Contains: 05030267069569
Package: [25 Units]
In Commercial Distribution
GS105030267069569 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CBPValve, Non-Rebreathing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-24
Device Publish Date2024-09-16

Devices Manufactured by Intersurgical Incorporated

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05030267161928 - 22MM FLEXTUBE SINGLE H/W LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB.>1.6M2025-03-24 22MM FLEXTUBE SINGLE HEATED WIRE LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB. > 1.6M
00816472020435 - Filta-Therm™ HMEF with luer port, retainable cap and Flextube™2025-02-11 Filta-Therm™ HMEF with luer port, retainable cap and Flextube™

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