Duns Number:066886996
Device Description: Crushield Pill Crusher Pouch with ENFit Twist-Lock Connector Cap
Catalog Number
-
Brand Name
Crushield
Version/Model Number
BCSP01
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
Yes
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
KYW
Product Code Name
Container, Liquid Medication, Graduated
Public Device Record Key
a2cd0cea-69c0-4e02-bec9-62be97197564
Public Version Date
August 17, 2022
Public Version Number
1
DI Record Publish Date
August 09, 2022
Package DI Number
10852359007332
Quantity per Package
50
Contains DI Package
00852359007335
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PKG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |