Duns Number:005146311
Device Description: ALL-IN-ONE Container, Empty EVA Container with Three Lead Transfer Set, 3000 mL Capacity
Catalog Number
2B8134
Brand Name
ALL-IN-ONE
Version/Model Number
2B8134
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2021
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
K090096,K090096
Product Code
KPE
Product Code Name
CONTAINER, I.V.
Public Device Record Key
d6d2b3da-088f-4247-aa53-acb3bc66f36b
Public Version Date
December 31, 2021
Public Version Number
7
DI Record Publish Date
September 24, 2016
Package DI Number
50085412041419
Quantity per Package
15
Contains DI Package
00085412041414
Package Discontinue Date
December 31, 2021
Package Status
Not in Commercial Distribution
Package Type
CASE
| 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. | 358 |