Duns Number:067486548
Device Description: UltraWarmer Ultrasound Gel Warmer for one: 250ml bottle. Red.
Catalog Number
36-1100-03
Brand Name
Pharmaceutical Innovations
Version/Model Number
UltraWarmer Gel Warmer - Red
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EFC
Product Code Name
Warmer, Anesthetic Tube
Public Device Record Key
9ac3527f-287b-4b99-8bbb-45677adcafaf
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 20, 2016
Package DI Number
10300361100034
Quantity per Package
1
Contains DI Package
00300361100037
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |