Duns Number:053469565
Device Description: Tamper evident cap for use with ENFit syringes; red; non-sterile; bag of 100; package of 1 Tamper evident cap for use with ENFit syringes; red; non-sterile; bag of 100; package of 1000; provides positive closure and tamper evidence.
Catalog Number
57-220 R
Brand Name
Tamper Evident Cap for use with ENFit Syringes
Version/Model Number
57-220 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
K170672,K170672,K170672
Product Code
PNR
Product Code Name
Enteral Syringes With Enteral Specific Connectors
Public Device Record Key
e26e1a48-f5e4-4bd5-ac74-61a19a750193
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
January 29, 2018
Package DI Number
B21257220R2
Quantity per Package
1000
Contains DI Package
B21257220R1
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 |