Duns Number:025460908
Device Description: INTEGRATOR, STEAM, MIGRATING CL5
Catalog Number
MDS200615
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
MDS200615
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K150477,K150477
Product Code
JOJ
Product Code Name
Indicator, physical/chemical sterilization process
Public Device Record Key
f0d5fa64-7955-4664-91b1-d2885a47336f
Public Version Date
February 04, 2022
Public Version Number
1
DI Record Publish Date
January 27, 2022
Package DI Number
20884389180478
Quantity per Package
1000
Contains DI Package
10884389180471
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |