Duns Number:595138793
Device Description: a 2-way Adset of tube lengths 60" with 1 line connected to a 3cc transducer and pressure t a 2-way Adset of tube lengths 60" with 1 line connected to a 3cc transducer and pressure tubing of lengths 72" and 12" and stopcocks. The other line is left open for other connection. It includes a separately packed 3xmale, 1x Female protective caps and a Colour Set
Catalog Number
687195
Brand Name
MEMORIAL SLOAN KETTERING PRI SET
Version/Model Number
687195
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
3571e1f1-d70b-4762-aac2-e6140456ce10
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
50886333671958
Quantity per Package
20
Contains DI Package
00886333671953
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 |