FDA.reportPublic FDA data

Resp-O2 Tracheostomy Adult Mask

Primary DI
00840117318069
Brand
Resp-O2 Tracheostomy Adult Mask
Company
Dynarex Corporation
Model
34020
Device description
with Swivel Tubing Connector (5.4 mm) Adaptor
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
BYGMask, Oxygen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYGMask, OxygenAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840117308602PackageGS150In Commercial Distribution
00840117318069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840117308602008401173086028401173086020840117308602
00840117318069008401173180698401173180690840117318069

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy mask, oxygenA device designed to deliver oxygen or a mixture of oxygen and air to a patient who has a tracheostomy airway. It is connected to an oxygen/medical air source with tubing and is constructed of plastic. The device can be used over a tracheal tube or stoma. 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

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