FDA.reportPublic FDA data

Guedel Airway, Size 9.0

Primary DI
06923310902953
Brand
Guedel Airway, Size 9.0
Company
Hangzhou Formed Medical Devices Co.Ltd.
Model
PA040109
Catalog number
PA040109
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
06923310902953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06923310902953069233109029536923310902953

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
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
06923310902960Guedel Airway, Size 10.0PA040110PA0401102022-12-13
06923310902977Guedel Airway, Size 11.0PA040111PA0401112022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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