Duns Number:106712748
Catalog Number
-
Brand Name
Graseby
Version/Model Number
21-0349-25
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
K894360,K894360
Product Code
FRN
Product Code Name
Pump, infusion
Public Device Record Key
64354bdc-2c01-4cfc-b711-ae7fb7e6e6c4
Public Version Date
August 17, 2018
Public Version Number
4
DI Record Publish Date
October 13, 2016
Package DI Number
30610586100509
Quantity per Package
40
Contains DI Package
00610586100508
Package Discontinue Date
-
Package Status
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 686 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 1 |