AccessGUDID - DEVICE: DG Therm (08437014205169)

GUDID

Device Identifier (DI) Information

Brand Name: DG Therm
Version or Model: 213734
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 213734
Company Name: DIAGNOSTIC GRIFOLS SA

Primary DI Number: 08437014205169
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 463625602 *Terms of Use

Device Description: DG THERM Incubator is a device specifically designed to incubate DG Gel 8 Cards and/or test tubes at 37oC for inmmunohematology applications.

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):	Yes
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?
64818	Microplate/tube/assay card incubator IVD	An electrically-powered device intended to be used for the uniform heating of the contents of a microplate, test tube, and/or assay/reagent/test card, as part of an incubation step required during the in vitro diagnostic processing of a clinical specimen. It typically consists of a heat-conducting panel/unit on which the microplate/tube/card is placed, and an electronically-controlled heating element for precise temperature control. It may also be referred to as a heater and may be used as a stand-alone device or a modular component as part of a system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PBC	Manual Blood Grouping And Antibody Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK120046	0

Device Exempt from Premarket Submission: No 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: 23b51e9f-41a3-4307-8b3a-9183d60a6be5
Public Version Date: April 29, 2025
Public Version Number: 4
DI Record Publish Date: September 06, 2016