AccessGUDID - DEVICE: Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software (00664369000639)

GUDID

Device Identifier (DI) Information

Brand Name: Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software
Version or Model: UF-1000i with UF WAM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Sysmex America, Inc.

Primary DI Number: 00664369000639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021860424 *Terms of Use

Device Description: Fully Automated Urine Cell Analyzer UF-1000i UF WAM

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?
57839	Flow cytometry analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LKM	COUNTER, URINE PARTICLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080887	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: 2a99a7ea-493b-4efe-8777-2aba62fc0430
Public Version Date: September 16, 2022
Public Version Number: 4
DI Record Publish Date: August 04, 2016