FDA.reportPublic FDA data

One Degree Medical

Primary DI
10860003583002
Brand
One Degree Medical
Company
ONE DEGREE MEDICAL HOLDINGS, LLC
Model
ODM-1000
Device description
Fluid Warmer Drape 44" x 44" (ODM-1000)
Published
2020-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860003583002PackageGS124In Commercial Distribution
00860003583005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000358300210860003583002
00860003583005008600035830058600035830050860003583005

GMDN Terms#

Term, Definition table
TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
762-354-2048customerservice@onedegreemedical.com

Regulatory Flags#

DUNS number
065180232
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
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
00860003583050One Degree MedicalODM-30382021-02-24
00860003583067One Degree MedicalODM-STN012021-02-24
10860003583026One Degree MedicalODM-20382020-08-03
10860003583033One Degree MedicalODM-20662020-08-03
10860003583019One Degree MedicalODM-11002020-06-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998192814Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998304996Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305016Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305030Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305078Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305092Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305115Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305139Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998305153Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312373Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312397Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312434Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312458Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312472Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998312496Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329678Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329708Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329739Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329760Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329791Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329821Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998329852Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330032Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330124Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330216Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330278Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330308Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330346Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330360Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23
00197998330438Solventum™ Steri-Drape™Solventum US LLCPUI2026-08-23