Duns Number:066175613
Device Description: 30ml enfit non-sterile clear syringe
Catalog Number
ENF30-KSBC
Brand Name
Ameritus ENFit
Version/Model Number
ENF30-KSBC
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
Yes
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
K162188,K162188,K162188,K162188
Product Code
PNR
Product Code Name
Enteral Syringes With Enteral Specific Connectors
Public Device Record Key
bf8fdda3-82bb-4cfa-9291-8bee06fac0a2
Public Version Date
October 29, 2021
Public Version Number
5
DI Record Publish Date
March 28, 2019
Package DI Number
30817522011534
Quantity per Package
800
Contains DI Package
10817522011530
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |