FDA.reportPublic FDA data

Berman Airway

Primary DI
04719872108788
Brand
Berman Airway
Company
ENTER MEDICAL CORPORATION
Model
PN-2001
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.
Published
2023-06-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTQAirway, Nasopharyngeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719872108788PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872108788047198721087884719872108788

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658833116
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
04719872100607RESERVOIRPN-06012023-10-19
04719872101208Seal Rite Mask1202023-10-19
04719872102021Catheter MountPN-20252023-10-19
04719872103028Bubble HumidifierPN-302-012023-10-19
04719872104414Nasal CannulaPN-20132023-10-19
04719872104568reusable resuscitatorENT-10222023-10-19
04719872109631Disposable ResuscitatorENT-10012023-10-19
04719872109853Anaesthetic Face MaskPN-05062023-10-19
04719872102014Oxygen TubeENT-20232023-09-28
047198721088012M TubeENT-20232023-09-28
04719872109501Breathing CircuitENT-20232023-09-28
04719872109532Breathing CircuitENT-20232023-09-28
04719872109723HEAD STRAPENT-20232023-09-28
04719872102007LARYNGOSCOPEENT-20022023-06-19
04719872103929Silicone maskPN-0503-22A2023-06-19
04719872104124Water TrapENT-20132023-06-19
04719872108764Bite BlockPN-6002023-06-19
04719872108795Teeth Screw DriverPN-20022023-06-19
04719872101017mada10282015-10-14
04719872101024mada14342015-10-14

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00612479273337McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273351McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
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00612479273436McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
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00810094576691CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576707CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576714CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576721CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
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00810094576752CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
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00810003751102KENOREXKENTRON HEALTHCARE, INC.BTQ2024-04-14