Duns Number:186855925
Device Description: replacement sterile table pack in the event the sterility of the IPH table pack has been c replacement sterile table pack in the event the sterility of the IPH table pack has been compromised.
Catalog Number
111-3025
Brand Name
ThermoChem
Version/Model Number
IPH Table Pack replacement
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
MLW
Product Code Name
Warmer, Peritoneal Dialysate
Public Device Record Key
a6a2427d-e313-49e8-87fc-1ddbfd0c031b
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 20, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |