Catalog Number

PMB01B-N

Brand Name

AVANOS

Version/Model Number

47058

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K181360,K181360

Product Code

MEB

Product Code Name

Pump, infusion, elastomeric

Public Device Record Key

7100c845-6004-47b7-a9b6-c9d4254c3b82

Public Version Date

July 13, 2020

Public Version Number

1

DI Record Publish Date

July 03, 2020

Package DI Number

10193494470583

Quantity per Package

5

Contains DI Package

00193494470586

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS