Catalog Number

-

Brand Name

RTC 21-D Metered Dose Inhaler Adapter

Version/Model Number

RTC 21-D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

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

K981249,K981249

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

d6d8b0ca-a68d-419c-9703-2844ea517a0a

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 30, 2016

Package DI Number

M996RTC21D5

Quantity per Package

50

Contains DI Package

M996RTC21D0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Ziplock bag