Duns Number:831704841
Device Description: MediBag-250 mL Dual Port (Needleless and Spike Ports)
Catalog Number
220529
Brand Name
MediBag
Version/Model Number
220529
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
K001287,K001287,K001287
Product Code
KPE
Product Code Name
Container, I.V.
Public Device Record Key
d61f2f75-e861-4024-b384-52dbc7b93dac
Public Version Date
September 13, 2019
Public Version Number
1
DI Record Publish Date
September 05, 2019
Package DI Number
20857595005835
Quantity per Package
60
Contains DI Package
00857595005831
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 70 |