Duns Number:076681238
Device Description: Warming Cabinet 30"W x 35 1/2"H x 26 5/8"D w/(1) Solid Door w/(2) Adj Shelves
Catalog Number
14B7922200
Brand Name
Warming Cabinet
Version/Model Number
7922TS
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LHC
Product Code Name
Warmer, Irrigation Solution
Public Device Record Key
509cd92a-c8ce-442d-8db2-7cbf1c371f8d
Public Version Date
April 19, 2022
Public Version Number
1
DI Record Publish Date
April 11, 2022
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 | 57 |
2 | A medical device with a moderate to high risk that requires special controls. | 4 |