AccessGUDID - DEVICE: TEST1 THL (08056040141519)

GUDID

Device Identifier (DI) Information

Brand Name: TEST1 THL
Version or Model: TEST1 THL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SI 195.210/THL
Company Name: ALIFAX SRL

Primary DI Number: 08056040141519
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435930630 *Terms of Use

Device Description: TEST-1 THL - ESR automated analyzer, with Software for Latex Controls. Using different CBC rack metal adaptors.

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):	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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -20 and 65 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b96403c3-cfa1-414f-b73d-72f6e95e38be
Public Version Date: October 14, 2022
Public Version Number: 1
DI Record Publish Date: October 06, 2022