Duns Number:368457563
Device Description: Breathing Circuit, Expandable, Adult, Disposable, 2.4 m/96 in With HMEF 750/S, Gas Samplin Breathing Circuit, Expandable, Adult, Disposable, 2.4 m/96 in With HMEF 750/S, Gas Sampling Elbow, Manual Bag, 3L, Size 6 Mask with Hook Ring and Gas Sampling Line, 3m
Catalog Number
-
Brand Name
Vital Signs™
Version/Model Number
M1085513
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
CAH
Product Code Name
Filter, Bacterial, Breathing-Circuit
Public Device Record Key
d20fae06-740c-4b4e-914f-baa790cdaf96
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
September 01, 2019
Package DI Number
20190752109046
Quantity per Package
20
Contains DI Package
10190752109049
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 | 13 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 600 |