Duns Number:867673159
Device Description: RegMini, Blue, 0-8L,w/EK-1, CGA870, 1/e
Catalog Number
-
Brand Name
Drive
Version/Model Number
183500M
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"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAN
Product Code Name
REGULATOR, PRESSURE, GAS CYLINDER
Public Device Record Key
b16402fb-fd05-4b1c-9aa7-03f8430e5163
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
July 10, 2017
Package DI Number
50822383578335
Quantity per Package
20
Contains DI Package
00822383578330
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 | 3783 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 832 |