Enteral Feeding - Guardian Warmer w/ Control Box Hangers, Evaluation - MEDELA, INC.

Duns Number:052002029

Device Description: Guardian Warmer w/ Control Box Hangers, Evaluation

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More Product Details

Catalog Number

-

Brand Name

Enteral Feeding

Version/Model Number

NGW2000M

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122449,K122449

Product Code Details

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Device Record Status

Public Device Record Key

a32d36c7-7238-425e-9a7b-b1e4b2a4fe58

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

10020451101696

Quantity per Package

1

Contains DI Package

00020451101699

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"MEDELA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 244