AccessGUDID - DEVICE: EUROArrayProcessor reagent tray set (04049016148265)

GUDID

Device Identifier (DI) Information

Brand Name: EUROArrayProcessor reagent tray set
Version or Model: ZM 9999-0640-5
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EUROIMMUN Medizinische Labordiagnostika AG

Primary DI Number: 04049016148265
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 322209263 *Terms of Use

Device Description: No description.

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):	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?
61298	General laboratory assay tray	A tray with multiple wells designed to contain volumes of reagents, buffers, and other materials for laboratory testing procedures (e.g., in vitro diagnostic) performed manually, or by a laboratory analyser. The wells may in addition be used to contain and mix reactants for reactions performed onboard the analyser. It is typically made of plastic (e.g., polypropylene) and is used with manual or automated liquid handling instruments or analysers. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NSU	Instrumentation For Clinical Multiplex 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4d1bce1e-6376-45b6-ad7e-60ca0f3bb80d
Public Version Date: March 13, 2023
Public Version Number: 1
DI Record Publish Date: March 03, 2023