Catalog Number

301-003767

Brand Name

MESI mTABLET TBI

Version/Model Number

MTABSYSTBI

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K213730

Product Code

JOM

Product Code Name

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Public Device Record Key

d847825c-17de-4870-8d64-7c157128c6c9

Public Version Date

May 03, 2022

Public Version Number

1

DI Record Publish Date

April 25, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-