Catalog Number

-

Brand Name

Sechrist Industries, Inc.

Version/Model Number

4100HRP-03-1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K100268

Product Code

CBF

Product Code Name

Chamber, Hyperbaric

Public Device Record Key

845359c5-52d7-4512-8933-88e431cda097

Public Version Date

December 04, 2018

Public Version Number

1

DI Record Publish Date

November 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-