AccessGUDID - DEVICE: Starrsed Control (08719189137125)

GUDID

Device Identifier (DI) Information

Brand Name: Starrsed Control
Version or Model: QRR049002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: RR Mechatronics Manufacturing B.V.

Primary DI Number: 08719189137125
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 491828953 *Terms of Use

Device Description: Control blood for Starrsed Instruments and procedures

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:	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?
55972	Erythrocyte sedimentation rate (ESR) IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative determination of erythrocyte sedimentation rate (ESR) of a whole blood clinical 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: d5bba400-a534-4878-9fd0-1ea4edf70a25
Public Version Date: December 13, 2022
Public Version Number: 1
DI Record Publish Date: December 05, 2022