AccessGUDID - DEVICE: m2000 (00884999006577)

GUDID

Device Identifier (DI) Information

Brand Name: m2000
Version or Model: 04J71-93
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04J71-93
Company Name: ABBOTT MOLECULAR INC.

Primary DI Number: 00884999006577
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 878263359 *Terms of Use

Device Description: Abbott m2000rt Optical Calibration Kit

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:	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?
61303	Thermal cycler nucleic acid instrument calibrator/control kit IVD	A collection of reagents and other associated materials of known characteristics intended to be used to calibrate or verify the performance of a thermal cycler nucleic acid instrument/analyser [e.g., real-time polymerase chain reaction (PCR) machine] to ensure its proper function prior to analysis/processing of clinical samples.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	CLINICAL SAMPLE CONCENTRATOR
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
Storage Environment Temperature: less than -10 Degrees Celsius
Special Storage Condition, Specify: Protect from Light

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3bfc2787-6e20-4236-a7d5-eaf6d8c2032e
Public Version Date: February 06, 2025
Public Version Number: 4
DI Record Publish Date: September 01, 2016

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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