FDA.reportPublic FDA data

One Degree Medical

Primary DI
00860003583050
Brand
One Degree Medical
Company
ONE DEGREE MEDICAL HOLDINGS, LLC
Model
ODM-3038
Device description
3.8L Capacity Fluid Warming Unit - ODM-3038
Published
2021-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LHCWarmer, Irrigation Solution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHCWarmer, Irrigation SolutionPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003583050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003583050008600035830508600035830500860003583050

GMDN Terms#

Term, Definition table
TermDefinition
Surgical fluid heating plateA mains electricity (AC-powered) device that consists of a plate surface and heating elements (i.e., electrically heated from mains power) intended to be used in the operating room (OR) to heat water/fluids used for flushing/rinsing during surgical interventions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065180232
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003583005One Degree MedicalODM-10002020-06-15
00860003583012One Degree MedicalODM-11002020-06-15
00860003583029One Degree MedicalODM-20382020-08-03
00860003583036One Degree MedicalODM-20662020-08-03
00860003583043One Degree MedicalODM-30662021-02-24
00860003583067One Degree MedicalODM-STN012021-02-24
10860003583026One Degree MedicalODM-20382020-08-03
10860003583033One Degree MedicalODM-20662020-08-03
10860003583002One Degree MedicalODM-10002020-06-15
10860003583019One Degree MedicalODM-11002020-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00748426146802Medline-MicrotekMicrotek Medical LLCLHC2026-05-20
00748426146925Medline-MicrotekMicrotek Medical LLCLHC2026-05-20
00748426146932Medline-MicrotekMicrotek Medical LLCLHC2026-05-20
00841027100485Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027100508Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101000Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101109Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101307Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027101314Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102793Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102809Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102816Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027102823Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00841027103059Pedigo Products, Inc. PEDIGO PRODUCTS, INC.LHC2025-11-26
00748426137855Medline-MicrotekMicrotek Medical LLCLHC2025-11-05
00748426143146Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143153Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143160Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143177Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143184Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143191Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143306Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143313Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143320Medline-MicrotekMicrotek Medical LLCLHC2025-10-14
00748426143139Medline-MicrotekMicrotek Medical LLCLHC2025-10-08
00748426140695Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140718Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140725Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140732Medline-MicrotekMicrotek Medical LLCLHC2025-04-18
00748426140749Medline-MicrotekMicrotek Medical LLCLHC2025-04-18