AccessGUDID - DEVICE: m2000 (00884999043497)

GUDID

Device Identifier (DI) Information

Brand Name: m2000
Version or Model: 08N88-001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 08N88-001
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999043497
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: m2000sp SYSTEM SOFTWARE, Release 8.0

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:	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?
43472	Laboratory instrument/analyser application software IVD	An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).	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 [?]
K092705	000

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: 58ae2e37-4af0-42d7-9fb8-f2c031b53378
Public Version Date: July 26, 2023
Public Version Number: 4
DI Record Publish Date: April 30, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)553-7042
Email: customerservice@abbottmolecular.com

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