AccessGUDID - DEVICE: Excyte® (03661540700613)

GUDID

Device Identifier (DI) Information

Brand Name: Excyte®
Version or Model: ESR Non-Vacuum Tube
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ELITechGroup B.V.

Primary DI Number: 03661540700613
Issuing Agency: GS1
Commercial Distribution End Date: December 23, 2021
Device Count: 50
Labeler D-U-N-S® Number*: 415733737 *Terms of Use

Device Description: No description.

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?
55974	Non-evacuated erythrocyte sedimentation rate (ESR) tube IVD	An open-ended glass or plastic tube, or other dedicated vessel, intended to be used alone or in combination with other IVDs (e.g., ESR analyser, scaled ruler) 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
GHC	Tube, 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: 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: 76f8c9e8-d923-4fca-8b5f-06f0f6fdf1c3
Public Version Date: December 28, 2021
Public Version Number: 3
DI Record Publish Date: November 24, 2016