Duns Number:053469565
Device Description: Red Tamper Evident Luer Lock Caps for IV Syringes. Sterile,Individually Blister Packed, bo Red Tamper Evident Luer Lock Caps for IV Syringes. Sterile,Individually Blister Packed, box of 100. Provides Evidence of Access and maintains sterility
Catalog Number
57-80
Brand Name
Tamper Evident Cap
Version/Model Number
57-80
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K861276,K861276
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
079008e8-7fb4-4f0a-b953-db7c7e3b1ee3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
B21257802
Quantity per Package
100
Contains DI Package
B21257801
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |