AccessGUDID - DEVICE: NeuMoDx™ 288 Molecular System (10814278020014)

GUDID

Device Identifier (DI) Information

Brand Name: NeuMoDx™ 288 Molecular System
Version or Model: 500100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 500100
Company Name: Neumodx Molecular, Inc.

Primary DI Number: 10814278020014
Issuing Agency: GS1
Commercial Distribution End Date: August 07, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 078667309 *Terms of Use

Device Description: NeuMoDx™ 288 Molecular System

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?
48031	Thermal cycler nucleic acid amplification analyser IVD, laboratory	An electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. Amplified product is detected and/or quantified using oligonucleotide markers as it is produced (i.e., in real-time) or at the end-point. The analyser may also isolate, extract and/or prepare nucleic acid from the clinical specimen and/or culture isolate prior to amplification.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OOI	real time Nucleic acid amplification system

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
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 and 28 Degrees Celsius
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Humidity: between 20 and 60 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Depth: 109.2 Centimeter
Width: 182.9 Centimeter
Height: 190.5 Centimeter

Device Record Status

Public Device Record Key: 8e0d588d-0c48-4bd8-853b-d596c23aa207
Public Version Date: August 08, 2025
Public Version Number: 7
DI Record Publish Date: March 29, 2019