Duns Number:053469565
Device Description: Tamper evident cap for use with ENFit syringes; red; Baxter; non-sterile; bag of 100; pack Tamper evident cap for use with ENFit syringes; red; Baxter; non-sterile; bag of 100; package of 1000; provides positive closure and tamper evidence.
Catalog Number
53310
Brand Name
Tamper Evident Cap for ENFit Syringe
Version/Model Number
53310
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
7ecb1ed8-64e1-4c8f-88cf-8d464cda12c6
Public Version Date
March 06, 2020
Public Version Number
4
DI Record Publish Date
January 29, 2018
Package DI Number
B212H938533102
Quantity per Package
10
Contains DI Package
B212H938533101
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 |