Duns Number:785952607
Device Description: INTER-THERM BREATHING FILTER/HME WITH PORT AND CATHETER MOUNT
Catalog Number
-
Brand Name
N/A
Version/Model Number
1341033S
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"
-
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
K092451,K092451
Product Code
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
3ae362d8-7d59-4fa5-8c2a-ceb3b9ba1cdc
Public Version Date
February 07, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
05030267083688
Quantity per Package
1
Contains DI Package
05030267083671
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 222 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |