RespVent™ RTG-01001

GUDID 10850108006025

RespVent HMEF 1000 Heat Moisture Exchanger with Intergrated Bacterial/Viral Filter, Sampling Port & Flex Tube. The Heat and Moisture Exchanger and Filter is a disposable single-use device indicated for patients who require humidification during the delivery of ventilator gases and provide filtration for reducing possible cross contamination between patient and equipment. The products mentioned above are designed for disposable use and should be changed at least every 24 hours.

CUTTING EDGE HC BRANDS LLC

Heat/moisture exchanger/microbial filter, non-sterile
Primary Device ID10850108006025
NIH Device Record Key80a84831-f732-4f3d-945e-6aba94cc9215
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespVent™
Version Model NumberRTG-01001
Catalog NumberRTG-01001
Company DUNS080216804
Company NameCUTTING EDGE HC BRANDS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, cool, dry place in original wrapper. Shelf life: Max. 3 years.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850108006028 [Primary]
GS110850108006025 [Package]
Contains: 00850108006028
Package: Carton [30 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CAHFilter, Bacterial, Breathing-Circuit

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-11
Device Publish Date2017-10-16

On-Brand Devices [RespVent™]

10850108006100RespVent HEPA Bacteria Viral Respiratory Filter is a disposable single-use device indicated for
10850108006094RespVent Universal Bacteria Viral Respiratory Filter is a disposable single-use device indicated
10850108006032RespVent HMEF 1000 Heat Moisture Exchanger with Intergrated Bacterial/Viral Filter. The Heat and
10850108006025RespVent HMEF 1000 Heat Moisture Exchanger with Intergrated Bacterial/Viral Filter, Sampling Por
10850108006018RespVent HMEF 1000 Heat Moisture Exchanger with Intergrated Bacterial/Viral Filter & Sampling Po
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