AccessGUDID - DEVICE: Reagent (04250317550705)

GUDID

Device Identifier (DI) Information

Brand Name: Reagent
Version or Model: 34966
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 34966
Company Name: Chromsystems Instruments + Chemicals GmbH

Primary DI Number: 04250317550705
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 328712260 *Terms of Use

Device Description: Pre-mixed Solution

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?
54434	Multiple vitamin IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of multiple vitamins in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JOA	Acid, Trifluoroacetic, Vitamin A, Hexane Extraction

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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20 ml

Device Record Status

Public Device Record Key: 2e43683a-9c41-45b8-ba55-bd3f12b64937
Public Version Date: September 04, 2020
Public Version Number: 1
DI Record Publish Date: August 27, 2020