RespVent™ RTG-01101

GUDID 10850108006100

RespVent HEPA Bacteria Viral Respiratory Filter is a disposable single-use device indicated for patient during the delivery of ventilator gases. They provide filtration for reducing possible cross contamination between patient and equipment. The RespVent Filter is for use in hospital, ICU, anesthesia, respiratory therapy, during transport and with resuscitators. The RespVent Filter can be used on adult patients. The RespVent Filter is indicated for use by qualified medical personnel only. The RespVent Filter is designed for disposable use and should be changed at least every 24 hours.

CUTTING EDGE HC BRANDS LLC

Heat/moisture exchanger insertable filter
Primary Device ID10850108006100
NIH Device Record Key0bac754a-f009-458f-becc-deabbd19934f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRespVent™
Version Model NumberRTG-01101
Catalog NumberRTG-01101
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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Weight33 Gram
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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.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850108006103 [Primary]
GS110850108006100 [Package]
Contains: 00850108006103
Package: Carton [25 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 Number3
Public Version Date2020-05-11
Device Publish Date2016-09-23

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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