Catalog Number

-

Brand Name

TEL-100 waterproof case(5lead AHA CLIP)

Version/Model Number

115-010673-00

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

K162607

Product Code

MSX

Product Code Name

System, Network And Communication, Physiological Monitors

Public Device Record Key

9156c797-9b3a-4af8-8370-c0aaf23b3c9f

Public Version Date

November 10, 2021

Public Version Number

3

DI Record Publish Date

April 30, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-