Catalog Number

-

Brand Name

AutoFuser

Version/Model Number

MT5015L

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MEB

Product Code Name

Pump, Infusion, Elastomeric

Public Device Record Key

0ec69f9a-34f9-4831-8172-5833a611a2c0

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 08, 2016

Package DI Number

88806139603703

Quantity per Package

100

Contains DI Package

08806139603707

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-