Duns Number:595138793
Device Description: 4x 3cc transducers, each connects to a port of a 5-Gang Multiport. The middle port connect 4x 3cc transducers, each connects to a port of a 5-Gang Multiport. The middle port connects directly with a 20 drops, 60" Adset. The other 4 ports, each connects with a 6" Pressure Tubing with clamp. The 4 x 3cc transducers are individually connected to these tubings. The zeroing stopcock of transducer in port # 1 connects with a 12" Pressure tubing, with red tape for identification, It has a 60" &12" Pressure tubings connect to it via 2 separate 3-way red stopcocks. Port #2, transducer is connected with a 24" Pressure tubing identified with Yellow tape and a 3-Way yellow stopcock. Port # 4, with its transducer connects to a Blue taped 24" pressure tubing and a 3-Way blue stopcock. Port # 5 connects with a transducer.
Catalog Number
686972
Brand Name
JEWISH HOSPITAL-OPEN HEART SET
Version/Model Number
686972
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
36c40bd1-c6f7-4199-afca-26dafcf40802
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
50886333669726
Quantity per Package
9
Contains DI Package
00886333669721
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 |