Catalog Number

L1-PWR-B

Brand Name

Level 1

Version/Model Number

L1-PWR-B

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"

-

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

K181699

Product Code

DWJ

Product Code Name

System, thermal regulating

Public Device Record Key

81a4269b-4e72-480c-bfc9-e4f00781ffc6

Public Version Date

September 17, 2018

Public Version Number

1

DI Record Publish Date

August 17, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-