Catalog Number

ENFCAP-BNS

Brand Name

Ameritus ENFit

Version/Model Number

ENFCAP-BNS

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

50ec07ce-6e96-461a-b7da-3644c32421d1

Public Version Date

July 01, 2019

Public Version Number

1

DI Record Publish Date

June 21, 2019

Package DI Number

30817522013231

Quantity per Package

10000

Contains DI Package

10817522013237

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case