AccessGUDID - DEVICE: NovaSeq™ 6000Dx Library Tube (00816270020552)

GUDID

Device Identifier (DI) Information

Brand Name: NovaSeq™ 6000Dx Library Tube
Version or Model: 20062290
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20062290
Company Name: ILLUMINA, INC.

Primary DI Number: 00816270020552
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033305264 *Terms of Use

Device Description: The Illumina NovaSeq™ 6000Dx Library Tube is intended to hold sample libraries for sequencing with NovaSeq 6000Dx S2 or S4 reagent kits and validated assays. The tube is boxed in one box, 20046942, NovaSeq™ 6000Dx Library Tube, which is labeled with the same Device Identifier.

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:	Yes
Prescription Use (Rx):	Yes
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?
62172	Laboratory waste receptacle IVD	A non-sterile container intended to collect and contain disposable materials/devices that have been contaminated due to contact with bodily fluids/substances (e.g., blood, sputum, urine, faeces) resulting from in vitro diagnostic procedures. It is typically in the form of a sack, box, or bottle made of durable plastic impervious to microorganisms. It may be used to collect solid and/or liquid waste from a laboratory instrument or analyser. This is a single-use device intended to be disposed of with its contents.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PFT	Reagents For Molecular Diagnostic Test Systems

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
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ef4ed7a2-9217-4b53-a72d-a1a8917cb7e9
Public Version Date: October 26, 2022
Public Version Number: 1
DI Record Publish Date: October 18, 2022