Duns Number:058614483
Device Description: Patient Warming System, Patient Warming Unit One Clip Nozzle
Catalog Number
502-2100
Brand Name
WarmTouch
Version/Model Number
502-2100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 01, 2019
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K123083
Product Code
DWJ
Product Code Name
System, thermal regulating
Public Device Record Key
e3debd49-bcce-47d3-9619-73bd48da70f7
Public Version Date
November 25, 2019
Public Version Number
6
DI Record Publish Date
August 03, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |