Duns Number:595138793
Device Description: 2x 3cc transducers, 1x 20 drops, 60" tube Adset & 2x 6" Pressure Tubing, each connected to 2x 3cc transducers, 1x 20 drops, 60" tube Adset & 2x 6" Pressure Tubing, each connected 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 2 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 72" Pressure tubing connected via s 3-way red stopcocks. Port #2, transducer is connected with a 12" Pressure tubing identified with Yellow tape and a 3-Way yellow stopcock. Port 4 & 5, each connected with 6" pressure Tubing. It also include a TBG, transducer mounting plate
Catalog Number
687341
Brand Name
JEWISH HOSP-DOUBLE LINE/BRIDGE SET
Version/Model Number
687341
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
e14e9aa8-2e81-470c-9b78-670091a665a6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 22, 2016
Package DI Number
50886333673419
Quantity per Package
9
Contains DI Package
00886333673414
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 |