Catalog Number

1126603

Brand Name

Alice 6

Version/Model Number

LDXN

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 9999

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

-

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

K040595

Product Code

OLV

Product Code Name

Standard polysomnograph with electroencephalograph

Public Device Record Key

27192290-f221-4af2-9e0f-0d97e55033eb

Public Version Date

November 12, 2018

Public Version Number

3

DI Record Publish Date

June 27, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-