Catalog Number

815030-000

Brand Name

SleepmateBody Position - Cadwell

Version/Model Number

815030-000

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 10, 2019

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K923033

Product Code

LXJ

Product Code Name

System, optical position/movement recording

Public Device Record Key

545eee7e-ae63-41ba-9bac-6cb8d8ecf143

Public Version Date

October 11, 2019

Public Version Number

2

DI Record Publish Date

January 03, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-