Duns Number:023904428
Device Description: Hot Pack McKesson Instant Chemical Activation General Purpose Small 5-1/2 X 6-3/4 Inch
Catalog Number
-
Brand Name
McKesson
Version/Model Number
59-57H
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IMD
Product Code Name
Pack, Hot Or Cold, Disposable
Public Device Record Key
08eeb8ac-c769-4b2c-ae09-1f19393aa02f
Public Version Date
July 23, 2020
Public Version Number
1
DI Record Publish Date
July 15, 2020
Package DI Number
00612479153370
Quantity per Package
24
Contains DI Package
00612479153363
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |