AccessGUDID - DEVICE: Monosed® ESR Vacuum Tubes, Carton (03661540300288)

GUDID

Device Identifier (DI) Information

Brand Name: Monosed® ESR Vacuum Tubes, Carton
Version or Model: PRD-PRV11B-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PRD-PRV11B-50
Company Name: ELITECHGROUP INC.

Primary DI Number: 03661540300288
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 16
Labeler D-U-N-S® Number*: 052423787 *Terms of Use

Device Description: ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocyte Sedimentation Rate (ESR) using ELITechGroup ESR analyzers. These devices are to be used by trained medical personnel only. The ESR tubes are intended for IN VITRO DIAGNOSTIC USE ONLY (IVD).

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:	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?
37558	Evacuated erythrocyte sedimentation rate (ESR) tube IVD	A sterile glass or plastic tube sealed with a stopper, or other dedicated vessel, containing a pre-measured amount of vacuum and the blood anticoagulant sodium citrate. It is intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled measure) for the quantitative determination of the erythrocyte sedimentation rate (ESR) of a whole blood clinical specimen. This is a single-use device.	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: 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: 53076546-bf91-483b-a726-85e7c864c8f1
Public Version Date: October 09, 2023
Public Version Number: 1
DI Record Publish Date: October 01, 2023