FDA.reportPublic FDA data

Resp-O2 Nasal Oxygen Cannula

Primary DI
00840117311503
Brand
Resp-O2 Nasal Oxygen Cannula
Company
DYNAREX CORPORATION
Model
33161
Device description
Resp-O2 Nasal Oxygen High Flow Cannula, Cushion Tip, 14' (4.3m) Crush Resistant Tubing, Adult Oxygen Flow Up to 15LPM, Standard Connector
Published
2021-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CATCannula, Nasal, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CATCannula, Nasal, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117311503PackageGS125In Commercial Distribution
00840117311497PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117311503008401173115038401173115030840117311503
00840117311497008401173114978401173114970840117311497

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration face tentA flexible, tent-like, enclosure designed to rest against the chin of the patient while remaining away from the face to provide a semi-enclosed environment of enriched oxygen (O2) to increase the patient's O2 uptake. It is connected to a high-flow O2 source and/or humidifier through wide bore tubing. It typically consists of a small rigid plastic device that is contoured around the chin and attached with head straps for stabilization. It is typically used for patients that are adverse to oxygen delivery devices such as a nasal cannula or face mask, usually due to facial surgery or trauma. This is not an O2 face mask. 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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305311Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301042021-04-22
00840117305335Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301052021-04-22
00840117305359Resp-O2 Hygroscopic Condenser Humidifier HMEF 1500301062021-04-22
00840117305373Resp-O2 Hygroscopic Condenser Humidifier HMEF 600301072021-04-22
00840117305397Resp-O2 Heat Moisture Exchange (HMEF) 1500 + (HEPA) Filter301122021-04-22
00840117305410Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult302012021-04-22
00840117305434Resp-O2 Heat Moisture Exchanger (HME) 1500, Adult, HCH, CO2 Port302032021-04-22
00840117305458Resp-O2 Heat Moisture Exchanger (HME) 1500, HCH, CO2 Port, Flex Tube302042021-04-22
00840117305472Resp-O2 Heat Moisture Exchanger (HME) 600, HCH, CO2 Port, Pediatric302052021-04-22
00840117305496Resp-O2 Pediatric/Neonatal Mini Tracheostomy (HME) 50302102021-04-22
00840117305557Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303022021-04-22
00840117305885Resp-O2 Heat Moisture Exchanger (HME) Tracheostomy with Side Oxygen Port303092021-04-22
00840117312340Resp-O2 Tracheostomy Drain Sponges, Non-woven,4"x4", 6-Ply350502022-05-02
00840117318090Resp-O2 Heat Moisture Exchanger (HME) 1500 With Integrated Flex Tube302022021-04-22
00840117318113Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy303032021-04-22
00840117318137Resp-O2 Heat Moisture Exchanger (HME) 1500 Tracheostomy303052021-04-22
00840117305519Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303002022-05-10
00840117305533Resp-O2 Heat Moisture Exchanger (HME) 1250 Tracheostomy303012022-05-10
00840117313545Resp-O2 Disposable Suction Canisters, 800 cc, Float Valve Shutoff, Locking Lid322012022-04-28
00840117305274Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301012021-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00607411919077Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919091Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919121Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-10
00607411919084MedTronic CannulaSALTER LABSCAT2026-06-09
00607411919107Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
00607411919138Salter Labs® Nasal CannulaSALTER LABSCAT2026-06-09
10197344155125MEDLINEMEDLINE INDUSTRIES, INC.CAT2026-01-29
10197344158478HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-10-17
10197344158409HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158416HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158423HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158430HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158447HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158454HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-26
10197344158461HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161164MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161171MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161188MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161195MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161201MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161218MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161225MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344161232MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-09-12
10197344155064MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344155101MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344158522MEDLINEMEDLINE INDUSTRIES, INC.CAT2025-08-21
10197344009664HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344009985HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344010004HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13
10197344011254HUDSON RCIMEDLINE INDUSTRIES, INC.CAT2025-05-13