Catalog Number

-

Brand Name

Multi-Site Attachment Ring for fragile/sensitive skin

Version/Model Number

MARe-SF

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

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

K151329,K101690,K071672,K041548,K041548,K071672,K101690,K151329

Product Code

DPZ

Product Code Name

Oximeter, Ear

Public Device Record Key

c861fb29-fe67-4906-8a0f-d565509ea28d

Public Version Date

March 01, 2019

Public Version Number

1

DI Record Publish Date

January 29, 2019

Package DI Number

17640121880800

Quantity per Package

24

Contains DI Package

07640121880803

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box