Duns Number:025460908
Device Description: CLIP,DRAPE,BARRIER
Catalog Number
MDSIVCLIP
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MDSIVCLIP
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
-
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
-
Product Code
FOX
Product Code Name
STAND, INFUSION
Public Device Record Key
a695c5d1-eae1-4b7d-943f-833da33c6083
Public Version Date
October 29, 2021
Public Version Number
1
DI Record Publish Date
October 21, 2021
Package DI Number
40884389164953
Quantity per Package
50
Contains DI Package
20884389164959
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 |