22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINE

GUDID 05030267045969

22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINE AND 6MM MONITORING LINE 1.8

INTERSURGICAL INCORPORATED

Ventilator breathing circuit, reusable
Primary Device ID05030267045969
NIH Device Record Key275f0c33-9675-4a5a-a59a-575820de217d
Commercial Distribution StatusIn Commercial Distribution
Brand Name22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM WITH 4MM CONTROL LINE
Version Model Number5191000
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 Datefalse
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
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
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com
Phone3154512900
Emailsupport@intersurgicalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS105030267045969 [Package]
Contains: 05030267069866
Package: [25 Units]
In Commercial Distribution
GS105030267069866 [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 Date2021-10-14
Device Publish Date2021-10-06

Devices Manufactured by INTERSURGICAL INCORPORATED

05030267033669 - 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M2025-03-24 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS. > 1.6M
05030267097913 - 22MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6M2025-03-24 22MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. > 1.6M
05030267033683 - 22MM SMOOTHBORE SINGLE H/W BREATHING SYSTEM WITH WATER TRAP AND LIMB.>1.6M2025-03-24 22MM SMOOTHBORE SINGLE HEATED WIRE BREATHING SYSTEM WITH WATER TRAP AND LIMB. > 1.6M
05030267096374 - 22MM SMOOTHBORE SINGLE H/W B/S WITH WATER TRAP,AUTO-FILL CHAMBER,EXTRA LIMB>1.6M2025-03-24 22MM SMOOTHBORE SINGLE HEATED WIRE BREATHING SYSTEM WITH WATER TRAP, AUTO-FILL CHAMBER AND EXTRA LIMB. > 1.6M
05030267033676 - 22MM SMOOTHBORE DUAL H/W BREATHING SYSTEM WITH EXTRA LIMB. > 1.6M2025-03-24 22MM SMOOTHBORE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMB. > 1.6M
05030267167678 - UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANT2025-03-24 UNIVERSAL STYLET BOUGIE (USB) WITHOUT SACHET OF LUBRICANT
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™

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.