Duns Number:004175550
Device Description: E-BLOCK SUB ASSY & HOSES ISO - This is an accessory only; not a medical device
Catalog Number
-
Brand Name
E-BLOCK SUB ASSY & HOSES ISO
Version/Model Number
C-1738-ISO
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAX
Product Code Name
Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Public Device Record Key
a317fb61-5e23-4a11-874c-fb822e3b3a67
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 30, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 20 |
2 | A medical device with a moderate to high risk that requires special controls. | 49 |