FDA.reportPublic FDA data

Bardex Nasopharyngeal Airway

Primary DI
10801741075695
Brand
Bardex Nasopharyngeal Airway
Company
C. R. Bard, Inc.
Model
055526
Catalog number
055526
Device description
Bardex Nasopharyngeal Airway (Robertazzi Model)
Published
2020-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

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
10801741075695PackageGS112In Commercial Distribution
00801741075698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174107569510801741075695
00801741075698008017410756988017410756980801741075698

GMDN Terms#

Term, Definition table
TermDefinition
Nasopharyngeal airway, single-useA rubber or plastic tube that extends into the pharynx from either naris to maintain airway patency. The proximal end of the device may have an integral 22 mm connector for oxygen delivery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge26French

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags#

DUNS number
016898496
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00801741011191N/A006172P006172P2015-06-29
00801741011207N/A006173P006173P2015-06-29
00801741011214N/A006221P006221P2015-06-29
00801741011221N/A006225P006225P2015-06-29
00801741011238N/A006241P006241P2015-06-29
00801741011245N/A006242P006242P2015-06-29
00801741011269NBIH™ Temporary Pacing Electrode Catheter007150P007150P2015-06-29
00801741011276NBIH™ Temporary Pacing Electrode Catheter007151P007151P2015-06-29
00801741011283NBIH™ Temporary Pacing Electrode Catheter007152P007152P2015-06-29
00801741011290NBIH™ Temporary Pacing Electrode Catheter007153P007153P2015-06-29
00801741011306GOETZ™ Temporary Pacing Electrode Catheter007154P007154P2015-06-29
00801741011313GOETZ™ Temporary Pacing Electrode Catheter007155P007155P2015-06-29
00801741011320GOETZ™ Temporary Pacing Electrode Catheter007156P007156P2015-06-29
00801741011337GOETZ™ Temporary Pacing Electrode Catheter007157P007157P2015-06-29
00801741011344NBIH™ Temporary Pacing Electrode Catheter007250P007250P2015-06-29
00801741011351NBIH™ Temporary Pacing Electrode Catheter007253P007253P2015-06-29
00801741011368NBIH™ Temporary Pacing Electrode Catheter007406P007406P2015-06-29
00801741011375NBIH™ Temporary Pacing Electrode Catheter007417P007417P2015-06-29
00801741011474NBIH™ Temporary Pacing Electrode Catheter057152P057152P2015-06-29
00801741011481NBIH™ Temporary Pacing Electrode Catheter057153P057153P2015-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840155421042Nasopharyngeal AirwayMEDSOURCE INTERNATIONAL LLCBTQ2025-07-15
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16920687310418MedisTianjin Medis Medical Device Co.,Ltd.BTQ2024-09-30
16920687310494MedisTianjin Medis Medical Device Co.,Ltd.BTQ2024-09-30
16920687310517MedisTianjin Medis Medical Device Co.,Ltd.BTQ2024-09-30
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00612479273429McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00612479273443McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
00810094576769CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
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00810094576790CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576806CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576813CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576820CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576837CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576844CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576851CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30
00810094576868CuraplexBOUND TREE MEDICAL, LLCBTQ2024-07-30