Reach - Pediatric lightweight pushchair with an - LEGGERO LLC

Duns Number:117338577

Device Description: Pediatric lightweight pushchair with an adjustable fixed tilt and folding frame.

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More Product Details

Catalog Number

-

Brand Name

Reach

Version/Model Number

3004

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

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

-

Product Code Details

Product Code

INM

Product Code Name

Chair, With Casters

Device Record Status

Public Device Record Key

ccbe2001-33c3-42be-a531-35141c8ac311

Public Version Date

May 13, 2021

Public Version Number

1

DI Record Publish Date

May 05, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LEGGERO LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4