Duns Number:442126587
Catalog Number
-
Brand Name
SH
Version/Model Number
14 - HEMOCONCENTRATOR
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
K081313,K081313
Product Code
KDI
Product Code Name
Dialyzer, high permeability with or without sealed dialysate system
Public Device Record Key
22dc80f8-b714-4f47-946b-347d07e6f64b
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 15, 2015
Package DI Number
38033178233638
Quantity per Package
12
Contains DI Package
08033178233637
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 398 |
| 3 | A medical device with high risk that requires premarket approval | 78 |