EC230L - 2.3 cu ft halo heat fluid warmer - ENTHERMICS, INC.

Duns Number:139782767

Device Description: 2.3 cu ft halo heat fluid warmer

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More Product Details

Catalog Number

-

Brand Name

EC230L

Version/Model Number

EC230L

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 2019

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

-

Product Code Details

Product Code

LGZ

Product Code Name

Warmer, Thermal, Infusion Fluid

Device Record Status

Public Device Record Key

2c8af2b3-459a-41c5-ab18-c0b714fda698

Public Version Date

March 22, 2022

Public Version Number

4

DI Record Publish Date

November 18, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ENTHERMICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 37