Duns Number:002054419
Device Description: Heat and Moisture Exchanger for patient end use, indicated for airway humidification of pa Heat and Moisture Exchanger for patient end use, indicated for airway humidification of patients undergoing mechanical ventilation
Catalog Number
HME40
Brand Name
Pall® Heat and Moisture Exchanger
Version/Model Number
HME40
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
-
Product Code
BYD
Product Code Name
CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE)
Public Device Record Key
5e9652f2-3b32-4c9c-8f9c-7ab0848b960b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 01, 2016
Package DI Number
30636207311291
Quantity per Package
50
Contains DI Package
00636207311290
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |