FDA.reportPublic FDA data

Trach O-Life

Primary DI
00850108006882
Brand
Trach O-Life
Company
CUTTING EDGE HC BRANDS LLC
Model
RTG-04016
Catalog number
RTG-04016
Device description
Adult Tracheostomy Mask, 22mm Swivel Tubing Connector & One Side Snap. The tracheostomy mask is used to administer aerosol or oxygen into tracheostomy of a surgical patient. It is intended for channeling gases for the purpose of administration of oxygen to patient. It is used to connect to an active medical device.
Published
2019-02-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
10850108006889PackageGS150In Commercial Distribution
00850108006882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085010800688910850108006889
00850108006882008501080068828501080068820850108006882

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy mask, aerosolA device designed to deliver air, oxygen, or a mixture of the two gases with aerosolized water particles to a patient who has a tracheostomy airway. It is typically connected to an oxygen source and nebulizer with wide bore tubing and is constructed of plastic. The device can be used over a tracheostomy tube or a stoma and is secured with a strap. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
9999999999info@rtghealth.com

Regulatory Flags#

DUNS number
080216804
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850108006011RespVent™RTG-01000RTG-010002017-10-16
00850108006028RespVent™RTG-01001RTG-010012017-10-16
00850108006035RespVent™RTG-01002RTG-010022017-10-16
00850108006097RespVent™RTG-01100RTG-011002016-09-23
00850108006103RespVent™RTG-01101RTG-011012016-09-23
00850108006042RespVent™RTG-01003RTG-010032022-12-30
00850108006059RespVent™RTG-01004RTG-010042022-12-30
00850108006066RespVent™RTG-01050RTG-010502022-12-30
00850108006073RespVent™RTG-01051RTG-010512022-12-30
00850108006080RespVent™RTG-01052RTG-010522022-12-30
00850108006110Adapt O-Life™RTG-19000RTG-190002022-12-30
00850108006127Trach O-Flex™RTG-19001RTG-190012022-12-30
00850108006134Trach O-Flex™RTG-19002RTG-190022022-12-30
00850108006141RespVac™RTG-02006RTG-020062022-12-30
00850108006158RespVac™RTG-02008RTG-020082022-12-30
00850108006165RespVac™RTG-02010RTG-020102022-12-30
00850108006172RespVac™RTG-02012RTG-020122022-12-30
00850108006189RespVac™RTG-02014RTG-020142022-12-30
00850108006196RespVac™RTG-02016RTG-020162022-12-30
00850108006202RespVac™RTG-02018RTG-020182022-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840118621144Endure IndustriesENDURE INDUSTRIESBYG2026-08-14
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04816415501379LARYNGEAL MASK Single Use Size 2ASSOMEDIKA, OOOBYG2026-05-27
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04816415501393LARYNGEAL MASK Single Use Size 5ASSOMEDIKA, OOOBYG2026-05-27
08697645018129ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018136ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
08697645018143ENDURE INDUSTRIESENDURE INDUSTRIESBYG2026-04-17
00848530108717Nasal CPAP MaskSunset Healthcare Solutions, Inc.BYG2026-04-07
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