FDA.reportPublic FDA data

RespVent™

Primary DI
00850108006080
Brand
RespVent™
Company
CUTTING EDGE HC BRANDS LLC
Model
RTG-01052
Catalog number
RTG-01052
Device description
RespVent Tracheostomy T- HME with Front Oxygen Port is a single use heat and moisture exchanger which transfers heat and humidity from the gas expired by the patient to the inspired gases. RespVent Trach T-HME is intended for use on patients who are breathing spontaneously through a tracheostomy tube.
Published
2022-12-30
Public version status
New
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
BYDCondenser, Heat And Moisture (Artificial Nose)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYDCondenser, Heat And Moisture (Artificial Nose)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850108006087PackageGS150In Commercial Distribution
00850108006080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085010800608710850108006087
00850108006080008501080060808501080060800850108006080

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger, single-use"A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an ""artificial nose"", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device."

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
9999999999info@respiratorytg.com

Regulatory Flags#

DUNS number
080216804
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
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
00850108006219RespVac™RTG-02106RTG-021062022-12-30

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Primary DI, Brand, Company table
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