Duns Number:023904428
Device Description: Instant Cold Pack McKesson General Purpose 6 X 9 Inch Disposable
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-9703
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
1736f024-ad06-4389-9d17-6b2d00aba5b4
Public Version Date
May 01, 2019
Public Version Number
1
DI Record Publish Date
April 23, 2019
Package DI Number
00612479134980
Quantity per Package
24
Contains DI Package
00612479134973
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 |