One Degree Medical

GUDID 00860003583067

Fluid Warming System Stand - ODM-STN01

ONE DEGREE MEDICAL HOLDINGS, LLC

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Primary Device ID00860003583067
NIH Device Record Keybfab8873-6f4b-48d5-b97e-ff59d4f33483
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne Degree Medical
Version Model NumberODM-STN01
Company DUNS065180232
Company NameONE DEGREE MEDICAL HOLDINGS, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100860003583067 [Primary]

FDA Product Code

LHCWarmer, Irrigation Solution

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-04
Device Publish Date2021-02-24

On-Brand Devices [One Degree Medical]

10860003583019Fluid Warmer Drape 44" x 66" (ODM-1100)
10860003583002Fluid Warmer Drape 44" x 44" (ODM-1000)
10860003583033Fluid Warmer Drape 44" x 60" (ODM-2066)
10860003583026Fluid Warmer Drape 44" x 60" (ODM-2038)
00860003583067Fluid Warming System Stand - ODM-STN01
008600035830503.8L Capacity Fluid Warming Unit - ODM-3038
008600035830436.6L Capacity Fluid Warming Unit - ODM-3066

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