Duns Number:080456871
Device Description: Patient Circuit, Expandable, Pediatric, Disposable, 2.4 m/96 in
Catalog Number
M1132638
Brand Name
Vital Signs™
Version/Model Number
M1132638
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
-
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
219ca848-d67d-4367-970b-3e34bd97c1c7
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
March 05, 2021
Package DI Number
70190752138096
Quantity per Package
20
Contains DI Package
10190752138094
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1068 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 780 |
| 3 | A medical device with high risk that requires premarket approval | 65 |
| U | Unclassified | 1 |