Timmy the Tiger Pediatric Nebulizer - Timmy the Tiger Pediatric Nebulizer - ARISE MEDICAL LLC

Duns Number:081149273

Device Description: Timmy the Tiger Pediatric Nebulizer

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More Product Details

Catalog Number

-

Brand Name

Timmy the Tiger Pediatric Nebulizer

Version/Model Number

240543

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

CAF

Product Code Name

Nebulizer (Direct Patient Interface)

Device Record Status

Public Device Record Key

e8f2774e-0319-469c-8d37-eb13d7d61445

Public Version Date

November 19, 2020

Public Version Number

2

DI Record Publish Date

August 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARISE MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 17