FDA.reportPublic FDA data

Ultra EX

Primary DI
06970888443852
Brand
Ultra EX
Company
Jiangxi Yiles Medical Co., Ltd
Model
Size 3.0
Catalog number
1038030
Device description
Laryngeal Mask Airway Reusable Size 3.0
Published
2023-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
16970888443859PackageGS110In Commercial Distribution
06970888443852PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697088844385916970888443859
06970888443852069708884438526970888443852

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mask airway, reusableA 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
561008872
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970888440547Ultra FlexSize 6.010370602024-03-02
06970888440493Ultra Flex Size 2.010370202024-03-02
06970888440509Ultra Flex Size 2.510370252024-03-02
06970888440516Ultra FlexSize 3.010370302024-03-02
06970888440523Ultra FlexSize 4.010370402024-03-02
06970888440530Ultra Flex Size 5.010370502024-03-02
16970888440490Ultra Flex Size 2.010370202024-03-02
16970888440506Ultra Flex Size 2.510370252024-03-02
16970888440513Ultra FlexSize 3.010370302024-03-02
16970888440520Ultra FlexSize 4.010370402024-03-02
16970888440537Ultra Flex Size 5.010370502024-03-02
06970888443869Ultra EXSize 4.010380402023-08-10
06970888443876Ultra EXSize 5.010380502023-08-10
06970888443951Ultra Flex EXSize 3.010390302023-08-10
06970888443968Ultra Flex EXSize 4.010390402023-08-10
06970888443975Ultra Flex EXSize 5.010390502023-08-10
06970888440011Ultra ClearSize 1.010360102023-05-05
06970888440028Ultra ClearSize 1.510360152023-05-05
06970888440059Ultra ClearSize 2.010360202023-05-05
06970888440080Ultra ClearSize 6.010360602023-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902224931LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-09-18
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06920687314068INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314075INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314082INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314099INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314105INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
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06920687314129INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
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06920687314143INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
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06920687314211INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314228INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314235INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314242INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314259INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314303INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314310INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314327INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06920687314334INTERSURGICALTianjin Medis Medical Device Co.,Ltd.CAE2026-08-26
06946430427632CompowerXIAMEN COMPOWER MEDICAL TECH. CO., LTDCAE2026-08-08