FDA.reportPublic FDA data

Laryngeal Mask Airway, Silicone Wire Reinforced, Size 4.0

Primary DI
16970706835415
Brand
Laryngeal Mask Airway, Silicone Wire Reinforced, Size 4.0
Company
Jiangxi Glance Medical Equipment Co., Ltd.
Model
UltraFlex 4.0
Catalog number
1037040
Device description
Laryngeal Mask Airway, Silicone Wire Reinforced, Size 4.0
Published
2023-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
16970706835415PackageGS110In Commercial Distribution
06970706835418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697070683541516970706835415
06970706835418069707068354186970706835418

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

Regulatory Flags#

DUNS number
526965604
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
06970706837009Laryngeal Mask Airway Silicone Size 6.0Ultra 6.010350602024-04-06
06970706835296Laryngeal Mask Airway Silicone Size 1.0Ultra 1.010350102023-07-25
06970706835302Laryngeal Mask Airway Silicone Size 1.5Ultra 1.510350152023-07-25
06970706835319Laryngeal Mask Airway Silicone Size 2.0Ultra 2.010350202023-07-25
06970706835326Laryngeal Mask Airway Silicone Size 2.5Ultra 2.510350252023-07-25
06970706835333Laryngeal Mask Airway Silicone Size 3.0Ultra 3.010350302023-07-25
06970706835340Laryngeal Mask Airway Silicone Size 4.0Ultra 4.010350402023-07-25
06970706835357Laryngeal Mask Airway Silicone Size 5.0Ultra 5.010350502023-07-25
06970706835364Laryngeal Mask Airway Silicone Wire Reinforced Size 1.0UltraFlex 1.010370102023-07-25
06970706835371Laryngeal Mask Airway Silicone Wire Reinforced Size 1.5UltraFlex 1.510370152023-07-25
06970706835388Laryngeal Mask Airway, Silicone Wire Reinforced, Size 2.0UltraFlex 2.010370202023-07-25
06970706835395Laryngeal Mask Airway, Silicone Wire Reinforced, Size 2.5UltraFlex 2.510370252023-07-25
06970706835401Laryngeal Mask Airway, Silicone Wire Reinforced, Size 3.0UltraFlex 3.010370302023-07-25
06970706835418Laryngeal Mask Airway, Silicone Wire Reinforced, Size 4.0UltraFlex 4.010370402023-07-25
06970706835425Laryngeal Mask Airway, Silicone Wire Reinforced, Size 5.0UltraFlex 5.010370502023-07-25
16970706835293Laryngeal Mask Airway Silicone Size 1.0Ultra 1.010350102023-07-25
16970706835309Laryngeal Mask Airway Silicone Size 1.5Ultra 1.510350152023-07-25
16970706835316Laryngeal Mask Airway Silicone Size 2.0Ultra 2.010350202023-07-25
16970706835323Laryngeal Mask Airway Silicone Size 2.5Ultra 2.510350252023-07-25
16970706835330Laryngeal Mask Airway Silicone Size 3.0Ultra 3.010350302023-07-25

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Primary DI, Brand, Company table
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06946430427632CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2026-08-08