Catalog Number

-

Brand Name

Level 1

Version/Model Number

PL-6

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

Yes

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

K072080,K072080

Product Code

LGZ

Product Code Name

Warmer, thermal, infusion fluid

Public Device Record Key

b7af9c4d-735d-4716-9221-9fe4d7ccab73

Public Version Date

February 24, 2020

Public Version Number

5

DI Record Publish Date

October 14, 2016

Package DI Number

50695085460204

Quantity per Package

20

Contains DI Package

30695085460200

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case