Duns Number:098791825
Device Description: Heating Pad, 12" x 15", Moist/Dry, On/Off Switch
Catalog Number
-
Brand Name
Blue Jay
Version/Model Number
BJ185100
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
-
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
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
15b337f4-18c9-4cd3-98d7-26067a934796
Public Version Date
July 07, 2020
Public Version Number
3
DI Record Publish Date
February 14, 2017
Package DI Number
10852321004673
Quantity per Package
12
Contains DI Package
00852321004676
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. | 3 |