Duns Number:025460908
Device Description: PATIENT MONITOR KIT
Catalog Number
DYKM1212
Brand Name
Medline Industries, Inc.
Version/Model Number
DYKM1212
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
K061573
Product Code
DRS
Product Code Name
TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
Public Device Record Key
eda5c5de-47bc-4517-9374-2b1a1f83793f
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
November 07, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| 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 |