Duns Number:078497467
Device Description: IAN 366501_2101 Heating Pad (Grey)SHK 22Art. No. 211.57/EAN 4211125211561Art. No 211.68/ E IAN 366501_2101 Heating Pad (Grey)SHK 22Art. No. 211.57/EAN 4211125211561Art. No 211.68/ EAN 4211125211684
Catalog Number
-
Brand Name
Vitalcontrol
Version/Model Number
SHK22 (Grey)
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"
-
For Single-Use
-
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
IRT
Product Code Name
Pad, Heating, Powered
Public Device Record Key
37cfe7d0-876d-4ee0-bd88-19963dad4cc7
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
October 31, 2021
Package DI Number
10850031772004
Quantity per Package
6
Contains DI Package
00850031772007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Inner Pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 90 |
| U | Unclassified | 2 |