Duns Number:002054419
Device Description: Adult 96" Expandable Dual Limb Circuit with Removable Limbs, 0.060" ID CO2 Gas Sampling Li Adult 96" Expandable Dual Limb Circuit with Removable Limbs, 0.060" ID CO2 Gas Sampling Line, and 2 Liter Non-Latex Breathing Bag.
Catalog Number
VM96DLEX2L
Brand Name
Ultipor™ Anesthesia Breathing Circuit System - Adult Machine Kit
Version/Model Number
VM96DLEX2L
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
1beb67f9-c821-439e-bf6c-a34e85bc2da2
Public Version Date
October 24, 2022
Public Version Number
4
DI Record Publish Date
June 29, 2016
Package DI Number
30636207315268
Quantity per Package
20
Contains DI Package
00636207315267
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 |