I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT 5194850

GUDID 05030267165322

I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT

Intersurgical Incorporated

Nasal oxygen cannula, basic
Primary Device ID05030267165322
NIH Device Record Key3cc093c8-8178-4c8c-9691-d18a340d867c
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT
Version Model Number7300001
Catalog Number5194850
Company DUNS785952607
Company NameIntersurgical Incorporated
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Device Identifiers

Device Issuing AgencyDevice ID
GS105030267165315 [Primary]
GS105030267165322 [Package]
Contains: 05030267165315
Package: [7 Units]
In Commercial Distribution

FDA Product Code

CATCannula, Nasal, Oxygen

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-01
Device Publish Date2025-09-23

Devices Manufactured by Intersurgical Incorporated

05030267165322 - I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT2025-10-01I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT
05030267165322 - I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT2025-10-01 I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT
05030267165346 - I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULT2025-10-01 I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULT
05030267165360 - HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULT2025-10-01 HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULT
05030267045952 - 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 2025-04-24 22MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE AND LIMB.1.6M
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
05030267098088 - PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M 2025-04-23 PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M
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

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