Duns Number:006959555
Device Description: Meijer Heat Wrap - Neck/Shoulder, 3-Count
Catalog Number
348707
Brand Name
Meijer
Version/Model Number
74-971
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OMW
Product Code Name
Adhesive Backed Thermal Skin Patches
Public Device Record Key
66ecc2d4-cf52-4942-a538-43e0d2ef3411
Public Version Date
December 15, 2020
Public Version Number
1
DI Record Publish Date
December 07, 2020
Package DI Number
30719283501234
Quantity per Package
4
Contains DI Package
00719283501233
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Intermediate
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 45 |
| U | Unclassified | 1 |