Duns Number:002054419
Device Description: Adult 120" Expandable Dual Limb Circuit, 0.060" ID CO2 Gas Sampling Line and 3 Liter Non-L Adult 120" Expandable Dual Limb Circuit, 0.060" ID CO2 Gas Sampling Line and 3 Liter Non-Latex Breathing Bag.
Catalog Number
VM120DLEX
Brand Name
Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit
Version/Model Number
VM120DLEX
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
K013093,K013093
Product Code
CAH
Product Code Name
Filter, bacterial, breathing-circuit
Public Device Record Key
6cc0d5df-f1b1-4c4b-9cf8-c8a5b317a3b3
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
June 29, 2016
Package DI Number
30636207315282
Quantity per Package
20
Contains DI Package
00636207315281
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 |