Duns Number:202659140
Device Description: The AMSCO Drying Cabinet, 29-inch with Pass Through with Purge and large shelves delivers The AMSCO Drying Cabinet, 29-inch with Pass Through with Purge and large shelves delivers unrivaled precision with exact temperature control, timers for every shelf and HEPA filtration.
Catalog Number
DCR101101XL
Brand Name
AMSCO
Version/Model Number
Drying 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
JRJ
Product Code Name
UNIT, DRYING
Public Device Record Key
fb434622-fffc-4cc4-848e-cfc43777d228
Public Version Date
November 18, 2021
Public Version Number
1
DI Record Publish Date
November 10, 2021
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 | 58 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 262 |