FDA.reportPublic FDA data

M SOLUS SINGLE USE LARYNGEAL MASK AIRWAY SIZE 4

Primary DI
05030267045570
Brand
M SOLUS SINGLE USE LARYNGEAL MASK AIRWAY SIZE 4
Company
INTERSURGICAL INCORPORATED
Model
8004002
Device description
M SOLUS SINGLE USE LARYNGEAL MASK AIRWAY SIZE 4
Published
2021-10-19
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
05030267045570PackageGS120In Commercial Distribution
05030267073566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05030267045570050302670455705030267045570
05030267073566050302670735665030267073566

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
05030267089123FIXED ELBOW, 15M - 22M/15F - STERILE1997000S2026-04-28
05030267169542SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER11430352026-04-21
05030267169573SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH TUBE, 2.1M USA ONLY11410352026-04-21
05030267169597SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO2 MONITORING LINE, FILTER11430382026-04-21
05030267169634SENTRI™ INTERSURGICAL ECOLITE™, ADULT, MASK WITH CO MONITORING LINE AND TUBE11420352026-04-21
05030267056057Y-PIECE 22M, 22M, 22M/15F19000002021-10-12
05030267056095Y-PIECE 22M, 22M, 22M/15F WITH PORTS19010002021-10-12
05030267056118Y-PIECE 15M, 15M, 15F19020002021-10-12
05030267056132Y-PIECE 15M, 15M, 22M/15F + 7.6MM PORTS, PAEDIATRIC19030002021-10-12
05030267056347PARALLEL Y-PIECE, 22MM19260002021-10-12
05030267056361PARALLEL Y-PIECE, 22M/15F -22M-22M WITH PORTS19270002021-10-12
05030267056408ADJUSTABLE Y-PIECE WITH SWIVEL NECK19290002021-10-12
00816472023726CO2 Sampling Line for Microstream® (Oridion®) capnography937160002023-01-13
05030267052257INTER-GUARD BREATHING FILTER WITH SUPERSET CATHETER MOUNT - STERILE1344711S2023-06-15
05030267054114CLEAR-GUARD3 ANGLED BREATHING FILTER WITH LUER PORT AND 22F/15M-22M/15F15450002023-06-15
05030267056279ONE-WAY DIRECTIONAL VALVE 22M FLOW IN-22F FLOW OUT19210002022-11-11
05030267057207T-PIECE, 22M, 22M/15F, 22M, WITH ONE-WAY VALVES19540002023-06-15
0503026706065822MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6M20260002025-03-14
0503026706071922MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6M20263102025-03-14
05030267064823MONITORING LINE 1.8M, MALE - MALE LUER LOCK CONNECTORS27250002024-02-20

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