FDA.reportPublic FDA data

Laryngeal Mask, Silicone Standard, Size 4.0

Primary DI
06923310903370
Brand
Laryngeal Mask, Silicone Standard, Size 4.0
Company
Hangzhou Formed Medical Devices Co.Ltd.
Model
PA010140
Catalog number
PA010140
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
06923310903370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923310903370069233109033706923310903370

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.

Regulatory Flags#

DUNS number
560463769
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06923310901291Naso-Pharyngeal Airway, Size 3.0PA190230PA1902302022-12-13
06923310901307Naso-Pharyngeal Airway, Size 3.5PA190235PA1902352022-12-13
06923310901314Naso-Pharyngeal Airway, Size 4.0PA190240PA1902402022-12-13
06923310901321Naso-Pharyngeal Airway, Size 4.5PA190245PA1902452022-12-13
06923310901338Naso-Pharyngeal Airway, Size 5.0PA190250PA1902502022-12-13
06923310901345Naso-Pharyngeal Airway, Size 5.5PA190255PA1902552022-12-13
06923310901352Naso-Pharyngeal Airway, Size 6.0PA190260PA1902602022-12-13
06923310901369Naso-Pharyngeal Airway, Size 6.5PA190265PA1902652022-12-13
06923310901376Naso-Pharyngeal Airway, Size 7.0PA190270PA1902702022-12-13
06923310901383Naso-Pharyngeal Airway, Size 7.5PA190275PA1902752022-12-13
06923310901390Naso-Pharyngeal Airway, Size 8.0PA190280PA1902802022-12-13
06923310901406Naso-Pharyngeal Airway, Size 8.5PA190285PA1902852022-12-13
06923310901413Naso-Pharyngeal Airway, Size 9.0PA190290PA1902902022-12-13
06923310902908Guedel Airway, Size 4.0PA040104PA0401042022-12-13
06923310902915Guedel Airway, Size 5.0PA040105PA0401052022-12-13
06923310902922Guedel Airway, Size 6.0PA040106PA0401062022-12-13
06923310902939Guedel Airway, Size 7.0PA040107PA0401072022-12-13
06923310902946Guedel Airway, Size 8.0PA040108PA0401082022-12-13
06923310902953Guedel Airway, Size 9.0PA040109PA0401092022-12-13
06923310902960Guedel Airway, Size 10.0PA040110PA0401102022-12-13

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Primary DI, Brand, Company table
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