Duns Number:025460908
Device Description: CONTAINER,CHEMO,12 GAL,PORT, YELLW, PGII
Catalog Number
MDS706312
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MDS706312
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
Yes
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
K071517,K071517
Product Code
MMK
Product Code Name
Container, sharps
Public Device Record Key
25ad0673-7df6-46b8-8ae6-0e30a0d49f09
Public Version Date
December 04, 2020
Public Version Number
1
DI Record Publish Date
November 26, 2020
Package DI Number
20888277408064
Quantity per Package
8
Contains DI Package
10888277408067
Package Discontinue Date
-
Package Status
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |