Duns Number:081057389
Device Description: HALYARD* Thermal Pad - Split Torso Large
Catalog Number
00315-08Z -No C
Brand Name
Halyard
Version/Model Number
94729
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 19, 2019
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DWJ
Product Code Name
System, thermal regulating
Public Device Record Key
4a9edc02-8332-4f03-ad7b-f5c3eefd3d1c
Public Version Date
November 20, 2019
Public Version Number
4
DI Record Publish Date
March 15, 2017
Package DI Number
30680651947292
Quantity per Package
5
Contains DI Package
10680651947298
Package Discontinue Date
November 19, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 24 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1044 |