Catalog Number

MT8060XL-CPNB

Brand Name

LMA

Version/Model Number

IPN046554

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

K090300,K090300

Product Code

MEB

Product Code Name

PUMP, INFUSION, ELASTOMERIC

Public Device Record Key

44c45070-bdb3-44bc-8263-8216c76512c7

Public Version Date

February 21, 2022

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

25060112312773

Quantity per Package

5

Contains DI Package

05060112312779

Package Discontinue Date

February 18, 2022

Package Status

Not in Commercial Distribution

Package Type

Box