Duns Number:324869601
Device Description: Dispo Infusor; for single use; for rapid pressure infusion and irrigation purposes
Catalog Number
-
Brand Name
n.a.
Version/Model Number
56-03-050
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
KZD
Product Code Name
Infusor, Pressure, For I.V. Bags
Public Device Record Key
36d51669-ee9b-4a81-a196-5d98e13356a5
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
August 31, 2020
Package DI Number
14250105608325
Quantity per Package
5
Contains DI Package
04250105608328
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 | 334 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |