Duns Number:036985604
Device Description: 6th Generation Mid-size Single Compartment Mobile Warming Cabinet is designed to raise the 6th Generation Mid-size Single Compartment Mobile Warming Cabinet is designed to raise the temperature of surgical IV and irrigation solutions and/or blankets to an acceptable level.
Catalog Number
DJ06014412313
Brand Name
Amsco
Version/Model Number
Warming Cabinet
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
LGZ
Product Code Name
Warmer, thermal, infusion fluid
Public Device Record Key
4eaa3e5a-3a3c-4d86-9ce7-45feb13a3ef5
Public Version Date
November 24, 2020
Public Version Number
2
DI Record Publish Date
June 11, 2020
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 | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |