Catalog Number

FCE1130B

Brand Name

MEDLINE INDUSTRIES, INC.

Version/Model Number

FCE1130B

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FNL

Product Code Name

BED, AC-POWERED ADJUSTABLE HOSPITAL

Public Device Record Key

26ded5f2-b5b6-4efe-bd93-d68d5d1c0829

Public Version Date

November 05, 2020

Public Version Number

1

DI Record Publish Date

October 28, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-