Duns Number:461437429
Device Description: Elastomeric Infusion Pump
Catalog Number
-
Brand Name
DOSI-FUSER
Version/Model Number
L25915-100D1-FDA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 09, 2018
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
K040752,K040752
Product Code
MEB
Product Code Name
Pump, Infusion, Elastomeric
Public Device Record Key
6fa39a17-efb5-45c2-a95f-71f02780ed5f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
Package DI Number
18436020763967
Quantity per Package
10
Contains DI Package
08436020763960
Package Discontinue Date
March 09, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 77 |