Catalog Number

NEB-TEDDY

Brand Name

The Aftermarket Group Pediatric Nebulizer

Version/Model Number

NBA02-A83

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

-

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

K043238,K043238

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Public Device Record Key

94bdf272-021b-47b6-bb8f-1d21a8aa41b5

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

10841447108037

Quantity per Package

6

Contains DI Package

00841447108030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-