Catalog Number

518085

Brand Name

PILLING

Version/Model Number

IPN008313

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"

Yes

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

K982128,K982128,K982128,K982128

Product Code

JOH

Product Code Name

Tube tracheostomy and tube cuff

Public Device Record Key

f2464c52-f506-4ef2-8f14-b7d4725ad454

Public Version Date

October 29, 2020

Public Version Number

5

DI Record Publish Date

October 12, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-