One Degree Medical - 3.8L Capacity Fluid Warming Unit - ODM-3038 - ONE DEGREE MEDICAL HOLDINGS, LLC

Duns Number:065180232

Device Description: 3.8L Capacity Fluid Warming Unit - ODM-3038

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More Product Details

Catalog Number

-

Brand Name

One Degree Medical

Version/Model Number

ODM-3038

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

-

Product Code Details

Product Code

LHC

Product Code Name

Warmer, Irrigation Solution

Device Record Status

Public Device Record Key

401425f7-aecb-4cdc-a7a7-567c5c034390

Public Version Date

March 04, 2021

Public Version Number

1

DI Record Publish Date

February 24, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ONE DEGREE MEDICAL HOLDINGS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 4