FDA.reportPublic FDA data

Ultra Flex

Primary DI
16970888440490
Brand
Ultra Flex
Company
Jiangxi Yiles Medical Co., Ltd
Model
Size 2.0
Catalog number
1037020
Device description
Laryngeal Mask Aiway Silicone Wire Reinforced Size 2.0
Published
2024-03-02
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
16970888440490PackageGS110In Commercial Distribution
06970888440493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697088844049016970888440490
06970888440493069708884404936970888440493

GMDN Terms#

Term, Definition table
TermDefinition
Reinforced laryngeal mask airway, single-useA curved armoured 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 is wire reinforced to prevent kinking during patient movement. It may include a 15 mm connector, 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
561008872
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
false
Sterilization required before use
false

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
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
06970888443852Ultra EXSize 3.010380302023-08-10
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
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501416SINGLE-USE OROPHARYNGEAL AIRWAY 90 mmASSOMEDIKA, OOOCAE2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmASSOMEDIKA, OOOCAE2026-05-27
10197344165605MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165612MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165629MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165636MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165643MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165650MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165667MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10197344165674MEDLINEMEDLINE INDUSTRIES, INC.CAE2026-01-12
10801902154054LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902154061LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902154078LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902154085LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-09-11
10801902153972LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902153989LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902153996LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154009LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154016LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154023LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154030LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154047LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154092LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154108LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10801902154115LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2025-04-30
10889483214107Air-Q®AIRLIFECAE2025-02-10
10889483214114Air-Q®AIRLIFECAE2025-02-10
10889483214121Air-Q®AIRLIFECAE2025-02-10
10889483480328Air-Q3®AIRLIFECAE2025-02-10