Duns Number:053469565
Device Description: Sterile Red Tamper Evident Luer Lock Caps for IV Syringes, in bulk transfer tray. Provides Sterile Red Tamper Evident Luer Lock Caps for IV Syringes, in bulk transfer tray. Provides evidence of access and maintains sterility.Packaged using double sterile barrier system: 10 caps per tray (with tyvek lid), 10 trays per Tyvek pouch, and 7 pouches per shipping box for a total of 700 caps per box.
Catalog Number
57-301 R
Brand Name
Tamper Evident Cap
Version/Model Number
57-301 R
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,K861276
Product Code
FMF
Product Code Name
Syringe, Piston
Public Device Record Key
c2408775-2373-4037-8463-ef26560a8eed
Public Version Date
February 21, 2020
Public Version Number
1
DI Record Publish Date
February 13, 2020
Package DI Number
B21257301R2
Quantity per Package
70
Contains DI Package
B21257301R1
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 |