AccessGUDID - DEVICE: One Degree Medical (00860003583050)

GUDID

Device Identifier (DI) Information

Brand Name: One Degree Medical
Version or Model: ODM-3038
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ONE DEGREE MEDICAL HOLDINGS, LLC

Primary DI Number: 00860003583050
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 065180232 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36815	Surgical fluid heating plate	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHC	Warmer, Irrigation Solution

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

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

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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