Duns Number:053469565
Device Description: Sterile Red Tamper Evident Caps with Male Luer Lock Fitting. Provides evidence of access a Sterile Red Tamper Evident Caps with Male Luer Lock Fitting. Provides evidence of access and maintains sterility. 1 Cap per sterile blister, 100 caps per shipper box
Catalog Number
57-91 R
Brand Name
Tamper Evident Cap with Male Luer Lock
Version/Model Number
57-91 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
K182545,K182545
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
32ea9297-7f9e-4e3d-b5d0-9b9a0dd44287
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
February 13, 2020
Package DI Number
B2125791R2
Quantity per Package
100
Contains DI Package
B2125791R1
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 |