Duns Number:595138793
Device Description: 80" Male/Male Clear Pressure Tubing
Catalog Number
682236
Brand Name
COMP PRLINE MM 80 IN (200CM) CLR
Version/Model Number
682236
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRS
Product Code Name
Transducer, Blood-Pressure, Extravascular
Public Device Record Key
629b42e7-9144-4262-8aa3-4e7bf5770542
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 30, 2016
Package DI Number
50886333622363
Quantity per Package
125
Contains DI Package
00886333622368
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Tyvek Bag
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 392 |