Duns Number:052002029
Device Description: Guardian Warmer
Catalog Number
-
Brand Name
Enteral Feeding
Version/Model Number
NGW1000
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
K122449,K122449
Product Code
LGZ
Product Code Name
Warmer, Thermal, Infusion Fluid
Public Device Record Key
f7fe1bd6-2629-4cb0-a8dc-69ab90d8bad2
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
September 22, 2016
Package DI Number
10020451100989
Quantity per Package
1
Contains DI Package
00020451100982
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 244 |