Duns Number:066886996
Device Description: Crushield is a safety pill crushing system that safely crushes, dissolves and delivers med Crushield is a safety pill crushing system that safely crushes, dissolves and delivers medication into a feeding tube. The crusher combined with an ENFit compatible pouch shields the user from hazardous drug dust.
Catalog Number
BCS01
Brand Name
Crushield
Version/Model Number
BCS01
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
OHY
Product Code Name
Pill Crusher/Cutter
Public Device Record Key
61cc7cb2-92aa-4b8a-b7bd-0182b49f0321
Public Version Date
August 30, 2022
Public Version Number
2
DI Record Publish Date
August 09, 2022
Package DI Number
00852359007397
Quantity per Package
8
Contains DI Package
00852359007342
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
cs
| 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 |