GUEDEL AIRWAY, SIZE 000, ISO 3.5

GUDID 05030267044511

GUEDEL AIRWAY, SIZE 000, ISO 3.5

Intersurgical Incorporated

Oropharyngeal airway, single-use
Primary Device ID05030267044511
NIH Device Record Keydf36658c-b7de-4661-a846-af9f4ecde97b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGUEDEL AIRWAY, SIZE 000, ISO 3.5
Version Model Number1000035
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS105030267044511 [Package]
Contains: 05030267049844
Package: [25 Units]
In Commercial Distribution
GS105030267044528 [Package]
Contains: 05030267049844
Package: [100 Units]
In Commercial Distribution
GS105030267049844 [Primary]

FDA Product Code

CAEAirway, Oropharyngeal, Anesthesiology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-02
Device Publish Date2023-05-25

Devices Manufactured by Intersurgical Incorporated

05030267011872 - GAS MONITORING LINE, 1.2MM ID, MALE/MALE LUER LOCK, 3M2024-11-01 GAS MONITORING LINE, 1.2MM ID, MALE/MALE LUER LOCK, 3M
05030267163571 - INTERSURGICAL ECOLITE™, ADULT, HIGH CONCENTRATION OXYGEN MASK AND TUBE, 2.1M2024-10-17 INTERSURGICAL ECOLITE™, ADULT, HIGH CONCENTRATION OXYGEN MASK AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M
05030267163588 - CIRRUS™2 NEBULISER MOUTHPIECE KIT AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M2024-10-17 CIRRUS™2 NEBULISER MOUTHPIECE KIT AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M
05030267163618 - CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT AND TUBE, 2.1M2024-10-17 CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M
05030267163595 - CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT AND TUBE, 2.1M2024-10-17 CIRRUS2 NEBULISER, PAEDIATRIC INTERSURGICAL ECOLITE MASK KIT AND TUBE WITH UNIVERSAL CONNECTOR, 2.1M
05030267167142 - CLEARLITE™ AIR, ANAESTHETIC FACE MASK, SIZE 4, ADULT, GREEN SEAL, 22F2024-10-17 CLEARLITE™ AIR, ANAESTHETIC FACE MASK, SIZE 4, ADULT, GREEN SEAL, 22F
05030267167166 - CLEARLITE™ AIR, ANAESTHETIC FACE MASK SIZE 4 ADULT GREEN SEAL NO HOOK RING 22F 2024-10-17 CLEARLITE™ AIR, ANAESTHETIC FACE MASK, SIZE 4, ADULT, GREEN SEAL, NO HOOK RING, 22F
05030267040865 - 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6M2024-09-24 22MM SMOOTHBORE REUSABLE EXHALATION VALVE BREATHING SYSTEM. 1.6M

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