Duns Number:007941230
Device Description: Instant Warm Pack Sodium Acetate Single Patient Use Flocked Non Woven 5.75 X 9 Inch Dispos Instant Warm Pack Sodium Acetate Single Patient Use Flocked Non Woven 5.75 X 9 Inch Disposable MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
CWP954
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
8dbc1093-da48-4ef6-98ff-6c56332145a6
Public Version Date
October 23, 2020
Public Version Number
1
DI Record Publish Date
October 15, 2020
Package DI Number
20885632061865
Quantity per Package
24
Contains DI Package
10885632061868
Package Discontinue Date
-
Package Status
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |