Duns Number:421290561
Device Description: 1133818
Catalog Number
-
Brand Name
Willis the Whale
Version/Model Number
1133818
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
-
Product Code
BTI
Product Code Name
Compressor, Air, Portable
Public Device Record Key
a9c27e78-ccc7-4e69-a315-94f98d55a3a5
Public Version Date
July 02, 2018
Public Version Number
1
DI Record Publish Date
June 01, 2018
Package DI Number
16946159504017
Quantity per Package
6
Contains DI Package
06946159504010
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. | 30 |