FDA.reportPublic FDA data

Resp-O2 Nasal Oxygen High Flow Cannula, Cushion Tip

Primary DI
00840117311473
Brand
Resp-O2 Nasal Oxygen High Flow Cannula, Cushion Tip
Company
Dynarex Corporation
Model
33160
Device description
7' (2.1m) Crush Resistant Tubing, Adult, Oxygen Flow up to 15 LPM, Standard Connector
Published
2021-04-22
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
CATCannula, Nasal, Oxygen

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117311480PackageGS125In Commercial Distribution
00840117311473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117311480008401173114808401173114800840117311480
00840117311473008401173114738401173114730840117311473

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.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305274Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301012021-04-22
00840117305298Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000301032021-04-22
00840117305656Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500301002021-04-22
00840117305847Resp-O2 Heat Moisture Exchanger + Filter (HMEF) 1500301022021-04-22
00840117307728Ever-Soft Positioning Wedge130012021-04-22
00840117307742Ever-Soft Positioning Wedge130022021-04-22
00840117307766Ever-Soft Positioning Wedge130032021-04-22
00840117321045Bari+Max Bariatric Gel Foam Wheelchair Cushion 24"x18"x3"130542021-04-22
00840117321052Bari+Max Bariatric Gel Foam Wheelchair Cushion 26"x20" "x3"130552021-04-22
00840117321090Bari+Max Bariatric Gel/Foam Cushion 22"x18"x3"130502021-04-22
00840117321106Bari+Max Bariatric Gel/Foam Cushion 24"x18"x3"130512021-04-22
00616784304113Dmecare Solutions Solid Seat Insert13041-162021-09-01
00616784304212DMECare Solutions Solid Seat Insert13041-182021-09-01
00616784304311DMECare Solutions Solid Seat Insert13041-202021-09-01
00616784304410DMECare Solutions Solid Seat Insert13041-222021-09-01
00616784304519DMECare Solutions Solid Seat Insert13041-242021-09-01
00840117321021Bariatric Reclining Wheelchair 24" with Elevating Leg Rest15015-24DELR2024-05-08
00840117321168DynaRide Pediatric Wheelchair with Footrest 12"15009-12DFR2024-05-09
00840117321175DynaRide Pediatric Wheelchair with Footrest 14"15009-14DFR2024-05-09
00840117322684Bariatric Reclining Wheelchair 26" with Elevating Leg Rest15015-26DELR2024-05-08

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