Duns Number:177939027
Device Description: Vital Signs Infusor, Pressure, 1000cc
Catalog Number
-
Brand Name
Vital Signs
Version/Model Number
IN900048
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 31, 2019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KZD
Product Code Name
Infusor, Pressure, For I.V. Bags
Public Device Record Key
aa01d388-4334-4208-8f58-c9e50fad467d
Public Version Date
March 19, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2016
Package DI Number
30817357020688
Quantity per Package
48
Contains DI Package
10817357020684
Package Discontinue Date
March 19, 2021
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 49 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 178 |