AccessGUDID - DEVICE: Fluoroo-Check Heating Block (00895160002649)

GUDID

Device Identifier (DI) Information

Brand Name: Fluoroo-Check Heating Block
Version or Model: Heating Block
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HB101
Company Name: NANO-DITECH CORPORATION

Primary DI Number: 00895160002649
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 126544316 *Terms of Use

Device Description: The Fluoro-Check TM Heating Block is an anti-temperature preservation device designed to obtain optimal temperature from reagents. The compact Digital-controlled Heating Block provides excellent space utilization and superior product quality.

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:	Yes
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?
15105	Heating block IVD	An electrically-powered device which is primarily a heating element, with or without a thermostat, that is built into a compact block and intended to be used as a stable dry heat source to heat in vitro diagnostic specimens/laboratory materials. It is typically a stand-alone instrument, or an interchangeable component of an in vitro diagnostic instrument/analyser. It is available in various sizes to accommodate microplates of varying sizes, and may include covers to minimize evaporation from microplates.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

FDA Premarket Submission

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

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
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Storage Environment Temperature: between -10 and 50 Degrees Celsius
Handling Environment Humidity: between 10 and 80 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ca6ac494-de60-4da8-b797-0a4af732a0b2
Public Version Date: June 29, 2023
Public Version Number: 5
DI Record Publish Date: February 20, 2020