AccessGUDID - DEVICE: Starrsed (08719189137781)

GUDID

Device Identifier (DI) Information

Brand Name: Starrsed
Version or Model: A0030112
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Mechatronics USA LLC

Primary DI Number: 08719189137781
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137005943 *Terms of Use

Device Description: Automated analyzer for in vitro determination of the Erythrocyte Sedimentation Rate (ESR) for human blood samples in conformity with the Westergren standard.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
56691	Erthrocyte sedimentation rate (ESR) analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to determine the erythrocyte sedimentation rate (ESR) of red blood cells in an anticoagulated whole blood specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKB	DEVICE, AUTOMATED SEDIMENTATION RATE

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Liquid Chemical

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: 5311d3b6-b139-4c2b-bf95-d417c851907a
Public Version Date: September 03, 2024
Public Version Number: 1
DI Record Publish Date: August 26, 2024