FDA.reportPublic FDA data

Resp-O2 Nasopharyngeal Airway Kit

Primary DI
00840117315273
Brand
Resp-O2 Nasopharyngeal Airway Kit
Company
DYNAREX CORPORATION
Model
36271
Device description
Resp-O2 Nasopharyngeal Airway Kit, (1) 20FR, (1) 22FR, (1) 24FR, (1) 26FR, (1) 28FR, (1) 30FR, (1) 32FR, (1) 34FR, (1) 36FR + 9 Packs of DynaLube
Published
2022-05-17
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
BTQAirway, Nasopharyngeal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTQAirway, NasopharyngealAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117315259PackageGS110In Commercial Distribution
00840117315273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117315259008401173152598401173152590840117315259
00840117315273008401173152738401173152730840117315273

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00616784709734Blood Pressure Cuff Kits, Sphygmomanometer, 3-Cuffs, Child, Adult, Large Adult70972017-11-21
00616784710327Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71032016-09-24
00616784710518Sphygmomanometer71052016-09-24
00616784710617Sphygmomanometer71062016-09-24
00616784711027Single Head Stethoscope, Single Head71102021-04-22
00616784711126Stethoscope Dual Head71112021-04-22
00616784711225PA SensiLance Pressure Activated Safety Lancets, Sterile71122021-05-21
00616784711423PA [SensiLance Pressure Activated Safety Lancets,Sterile71142021-05-21
00616784709833Blood Pressure Cuff Kits, Sphygmomanometer, 5-Cuffs, Infant, Child, Adult, Large70982017-11-21
00616784709529Digital Blood Pressure Monitor70952021-01-19
00616784709628Digital Blood Monitors70962021-01-19
00616784709925Blood Pressure Kit,Sphymomanometer with Dual Head Stethoscope70992016-09-24
00616784710020Blood Pressure Kit Sphygmomanometer with Stethoscope71002016-09-24
00616784710228Disposable ECG Snap Electrodes, With Pre-Gelled AG/AGCI Sensor71022016-09-24
00840117344761Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310612026-05-25
00840117344778Resp-O2 Closed Suction Endotracheal Catheter, 8 FR (2.6 mm)310622026-05-25
00840117346215Resp-O2 Closed Suction Endotracheal Catheter, 10 FR (3.3 mm)310632026-05-25
00840117349711IV Extension Sets Needle-Free Luer Lock Connector For Injection, Non-Toxic, 17"70612016-09-24
00840117349742IV Extension Sets Needle-Free Luer Lock Connector, Non-Toxic, 8" (20.3 cm)70622016-09-24
00616784706313IV Extension Sets Needle-Free Luer Lock Connector for Injection Non-Toxic70632024-03-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979032640055GOBENHUZHOU JUNDA INDUSTRY CO., LTD.BTQ2025-08-26
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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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00612479273368McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
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00612479273405McKessonMCKESSON MEDICAL-SURGICAL INC.BTQ2024-09-04
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