Duns Number:825673239
Device Description: AMSure® Heat and Moisture ExchangerCAUTIONS: Single Patient Use.Avoid freezing and excessi AMSure® Heat and Moisture ExchangerCAUTIONS: Single Patient Use.Avoid freezing and excessive heat.
Catalog Number
HME002
Brand Name
AMSure® Heat and Moisture Exchanger
Version/Model Number
1
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
dc91859d-2644-4c88-a0bc-be149c1a6544
Public Version Date
June 01, 2020
Public Version Number
1
DI Record Publish Date
May 22, 2020
Package DI Number
40704411012208
Quantity per Package
50
Contains DI Package
10704411012207
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |