Enteral Feeding - Guardian Warmer, Evaluation - MEDELA, INC.

Duns Number:052002029

Device Description: Guardian Warmer, Evaluation

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More Product Details

Catalog Number

-

Brand Name

Enteral Feeding

Version/Model Number

NGW1000M

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 14, 2018

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

c9ea9e8c-2c58-4b75-a2ba-bcfd0ada0fbf

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

September 22, 2016

Additional Identifiers

Package DI Number

10020451101689

Quantity per Package

1

Contains DI Package

00020451101682

Package Discontinue Date

August 14, 2018

Package Status

Not 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