Duns Number:534155213
Catalog Number
-
Brand Name
Chilling Block
Version/Model Number
2 syringes + 2 vials
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 03, 2021
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
LXG
Product Code Name
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Public Device Record Key
18f4420a-c6eb-40da-af8c-ca9c46db989d
Public Version Date
February 04, 2021
Public Version Number
4
DI Record Publish Date
March 13, 2019
Package DI Number
20854913006086
Quantity per Package
1
Contains DI Package
10854913006089
Package Discontinue Date
February 03, 2021
Package Status
Not in Commercial Distribution
Package Type
Carton Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 3 |