Duns Number:825673239
Device Description: AMShield® Disinfecting CapContains 70% IPA for Needle-Free Valves10 Pieces Mounted on a St AMShield® Disinfecting CapContains 70% IPA for Needle-Free Valves10 Pieces Mounted on a Strip
Catalog Number
DCF2500S
Brand Name
AMShield® Disinfecting Cap
Version/Model Number
1
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LKB
Product Code Name
Pad, Alcohol, Device Disinfectant
Public Device Record Key
0db35c64-214a-4519-9578-f3c00be916a7
Public Version Date
September 09, 2020
Public Version Number
3
DI Record Publish Date
March 20, 2020
Package DI Number
40704411011867
Quantity per Package
10
Contains DI Package
30704411011860
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |