22MM SMOOTHBORE DUAL H/W BREATHING SYSTEM WITH EXTRA LIMB. > 1.6M

GUDID 05030267033676

22MM SMOOTHBORE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMB. > 1.6M

Intersurgical Incorporated

Ventilator breathing circuit, single-use
Primary Device ID05030267033676
NIH Device Record Key5440a404-fa22-493a-8980-492a818b8a78
Commercial Distribution StatusIn Commercial Distribution
Brand Name22MM SMOOTHBORE DUAL H/W BREATHING SYSTEM WITH EXTRA LIMB. > 1.6M
Version Model Number5026000
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
GS105030267033676 [Package]
Contains: 05030267069163
Package: [10 Units]
In Commercial Distribution
GS105030267069163 [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

05030267124084 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M
05030267124091 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M
05030267124107 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F
05030267123582 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F
05030267124121 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F
05030267124077 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F2025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F
05030267124138 - ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 222025-10-03 ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22F
05030267165322 - I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT2025-10-01 I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT

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