FDA.reportPublic FDA data

SINGLE-USE OROPHARYNGEAL AIRWAY 90 mm

Primary DI
04816415501416
Brand
SINGLE-USE OROPHARYNGEAL AIRWAY 90 mm
Company
ASSOMEDIKA, OOO
Model
N/A
Device description
A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.
Published
2026-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
04816415501416PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04816415501416048164155014164816415501416

GMDN Terms#

Term, Definition table
TermDefinition
Oropharyngeal airway, single-useA curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device.

Regulatory Flags#

DUNS number
683522555
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
04816415501379LARYNGEAL MASK Single Use Size 2N/A2026-05-27
04816415501386LARYNGEAL MASK Single Use Size 3N/A2026-05-27
04816415501393LARYNGEAL MASK Single Use Size 5N/A2026-05-27
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 mmN/A2026-05-27
04816415501423SINGLE-USE OROPHARYNGEAL AIRWAY 110 mmN/A2026-05-27
04816415501430BREATHING BAG single use 500N/A2026-05-27
04816415501447BREATHING BAG single use 1000N/A2026-05-27
04816415501454BREATHING BAG single use 2000N/A2026-05-27
04816415501461BREATHING BAG single use 3000N/A2026-05-27
04816415501478BREATHING BAG reusable 500N/A2026-05-27
04816415501485BREATHING BAG reusable 1000N/A2026-05-27
04816415501492BREATHING BAG reusable 2000N/A2026-05-27
04816415501508BREATHING BAG reusable 3000N/A2026-05-27
04816415501256ESMARCH'S MEDICAL MUGS SINGLE-USEN/A2026-05-26
04816415501263FOOT URINE COLLECTORN/A2026-05-26
04816415501270BEDSIDE URINE COLLECTORN/A2026-05-26
04816415501287BREATHING MASK Single Use Size 0N/A2026-05-26
04816415501294BREATHING MASK Single Use Size 3N/A2026-05-26
04816415501300BREATHING MASK Single Use Size 6N/A2026-05-26
04816415501317BREATHING MASK Reusable Size 0N/A2026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704945310RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945327RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945334RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945341RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945358RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945365RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945372RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704945389RUSCHTELEFLEX INCORPORATEDCAE2026-07-24
14026704624697RUSCHTELEFLEX INCORPORATEDCAE2026-07-22
04719874951504Create BiotechCREATE BIOTECH CO., LTD.CAE2026-07-16
04719874957575Create BiotechCREATE BIOTECH CO., LTD.CAE2026-07-16
15060112315029LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-06-24
15060112315036LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-06-24
15060112315043LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDCAE2026-06-24
05030267169870I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169894I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.0, SMALL PAEDIATRIC, 10-25KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169917I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169931I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169955I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169979I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 1.5, INFANT, 5-12KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267169993I-GEL®, SUPRAGLOTTIC AIRWAY, SIZE 2.5, LARGE PAEDIATRIC, 25-35KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170012I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170036I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 4, MEDIUM ADULT, 50-90KG (US)Intersurgical IncorporatedCAE2026-06-02
05030267170050I-GEL® PLUS-A, SUPRAGLOTTIC AIRWAY, SIZE 5, LARGE ADULT, 90+KG (US)Intersurgical IncorporatedCAE2026-06-02
04816415501409SINGLE-USE OROPHARYNGEAL AIRWAY 40 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