Duns Number:595138793
Device Description: Single 1-way 60 drops, 60inch tube length Adset connected to a 3cc transducer. The zeroing Single 1-way 60 drops, 60inch tube length Adset connected to a 3cc transducer. The zeroing stopcock of the transducer is connected with a septum with a 84" pressure tubing and a 12" pressure tubing. The safedraw set comes with a 5cc syringe with touchguard stops at 2cc. It includes a separately packed 2x male protective caps and a colour Label Set.
Catalog Number
687702
Brand Name
DT-8412SDT
Version/Model Number
687702
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
5f297cbc-b2aa-412d-a705-5a0bb3f6558d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
50886333677028
Quantity per Package
20
Contains DI Package
00886333677023
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 |