Solus Laryngeal Mask Airway Kit, Size 1

GUDID 00816472021531

Solus Laryngeal Mask Airway Kit, Size 1

Intersurgical Incorporated

Laryngeal mask airway, single-use
Primary Device ID00816472021531
NIH Device Record Keyae37ace7-b11c-4ed8-9fe2-f510d7002fa9
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolus Laryngeal Mask Airway Kit, Size 1
Version Model Number8001032
Company DUNS785952607
Company NameIntersurgical Incorporated
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com
Phone315-451-2900
Emailsupport@intersurgicalinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100816472021524 [Primary]
GS100816472021531 [Package]
Contains: 00816472021524
Package: [10 Units]
In Commercial Distribution

FDA Product Code

CAEAirway, Oropharyngeal, Anesthesiology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-21
Device Publish Date2023-06-13

Devices Manufactured by Intersurgical Incorporated

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
00816472022552 - Nose Clip with Padding2025-04-22 Nose Clip with Padding
05030267161546 - 22mm Compact breathing system2025-04-22 22mm Compact breathing system with 3L bag, elbow, monitoring line, anesthetic face mask and HMEF >3m
05030267161751 - 22mm Compact breathing system2025-04-22 22mm Compact breathing system with 3L bag, monitoring line, HMEF, and Clearlite facemask >3 m

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