Duns Number:087687179
Device Description: Cassette with Patient Line
Catalog Number
-
Brand Name
ThermaCor 1200 Infusion System
Version/Model Number
PNC-1200
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"
Yes
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
K052055,K052055
Product Code
FRN
Product Code Name
Pump, infusion
Public Device Record Key
a0c20118-ca88-4041-b1ad-2286afe72542
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
July 15, 2016
Package DI Number
10857893006063
Quantity per Package
4
Contains DI Package
00857893006066
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 19 |