Duns Number:157506015
Device Description: DIALYSIS TRANSDUCER PROTECTOR - Tamper Evident Packaging
Catalog Number
MPC-85TE
Brand Name
Molded Products, Inc.
Version/Model Number
MPC-85TE
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K925978,K925978,K925978
Product Code
FIB
Product Code Name
Protector, Transducer, Dialysis
Public Device Record Key
2d26f2b0-1c05-4be3-8a21-75452f1b4494
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
December 16, 2016
Package DI Number
B144MPC85TE3
Quantity per Package
22
Contains DI Package
B144MPC85TE2
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |