Duns Number:654671304
Catalog Number
-
Brand Name
TUBE,NIBP,ADU/PED/INF,CONN,3M
Version/Model Number
6200-30-09688
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
K132038
Product Code
MWI
Product Code Name
MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
Public Device Record Key
aeb0573c-d4ff-4ef0-8ef4-db68eb45c3c4
Public Version Date
July 22, 2019
Public Version Number
4
DI Record Publish Date
September 23, 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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 1079 |