Duns Number:080216804
Device Description: RespVent HMEF 1000 Heat Moisture Exchanger with Intergrated Bacterial/Viral Filter, Sampli 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.
Catalog Number
RTG-01001
Brand Name
RespVent™
Version/Model Number
RTG-01001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132709,K132709
Product Code
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
80a84831-f732-4f3d-945e-6aba94cc9215
Public Version Date
January 31, 2022
Public Version Number
6
DI Record Publish Date
October 16, 2017
Package DI Number
10850108006025
Quantity per Package
30
Contains DI Package
00850108006028
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 54 |