FDA.reportPublic FDA data

M SOLUS SINGLE USE LARYNGEAL MASK AIRWAY SIZE 2.5

Primary DI
05030267045556
Brand
M SOLUS SINGLE USE LARYNGEAL MASK AIRWAY SIZE 2.5
Company
INTERSURGICAL INCORPORATED
Model
8025001
Device description
M SOLUS SINGLE USE LARYNGEAL MASK AIRWAY SIZE 2.5
Published
2021-10-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAEAirway, Oropharyngeal, Anesthesiology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAEAirway, Oropharyngeal, AnesthesiologyAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05030267045556PackageGS120In Commercial Distribution
05030267073641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267045556050302670455565030267045556
05030267073641050302670736415030267073641

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mask airway, single-useA curved tube with a distal inflatable cuff/mask intended to be used in inhalational anaesthesia and resuscitation to facilitate and secure airway patency for the delivery and exchange of gases in spontaneously breathing and ventilated patients. It is inserted into the hypopharynx above the glottis to create a seal and to prevent the tongue from obstructing the anatomical airway. It may include a 15 mm connector that attaches to a breathing circuit or manual resuscitator, be radiopaque, and have a built-in pilot balloon for cuff pressure monitoring. It is available in various sizes/designs and is typically made of silicone/plastic materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3154512900support@intersurgicalinc.com

Regulatory Flags#

DUNS number
785952607
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
true
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05030267124084ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 0, NEONATE 15M122000051948502025-09-25
05030267124091ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 1, INFANT, 15M122100051948502025-09-25
05030267124107ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION, SIZE 2, PAEDIATRIC, 22F122200051948502025-09-25
05030267123582ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 3, SMALL ADULT, 22F122300051948502025-09-25
05030267124121ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 4, MEDIUM ADULT, 22F122400051948502025-09-25
05030267124077ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 5, LARGE ADULT, 22F122500051948502025-09-25
05030267124138ANAESTHETIC FACE MASK WITH ADJUSTABLE AIR CUSHION,SIZE 6, EXTRA LARGE ADULT, 22122600051948502025-09-25
05030267165322I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, SMALL ADULT730000151948502025-09-23
05030267165346I-FLO HIGH FLOW NASAL CANNULA WITH ADAPTER, MEDIUM ADULT730100151948502025-09-23
05030267165360HIGH FLOW NASAL CANNULA WITH ADAPTER, LARGE ADULT730200151948502025-09-23
0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE 519185051918502025-04-16
0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6M519485051948502025-04-16
05030267001804TRACHEOSTOMY MASK, PAEDIATRIC120600012060002025-04-15
05030267098088PREMATURE, NASAL CANNULA WITH CURVED PRONGS AND TUBE, 2.1M 116000011600002025-04-15
0503026716528522MM SMOOTHBORE EXHALATION VALVE BREATHING SYSTEM WITH MONITORING LINE AND SWIVE518301051830102025-04-15
00816472022552Nose Clip with Padding143560002025-04-14
0503026716154622mm Compact breathing system21580192025-04-14
0503026716175122mm Compact breathing system21580122025-04-14
05030267166367I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG890300089030002025-04-14
05030267166466I-GEL® PLUS ANAESTHESIA, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG.890400089040002025-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16946430425208CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425215CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425222CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425239CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425246CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425253CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425260CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425277CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425284CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425291CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425307CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425314CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425321CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425338CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425345CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425352CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425369CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425376CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425383CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425390CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425406CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425413CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425420CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425437CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
16946430425444CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2025-12-24
45060112316102LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-12-10
35060112316112LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-11-17
00840117340428Resp-O2 Disposable Guedel Airway, 120 mm, Adult XX-Large, Lavender Dynarex CorporationCAE2025-09-29
25060112310618LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
15060112311038LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11