AccessGUDID - DEVICE: VMA-SKREEN (00810042682283)

GUDID

Device Identifier (DI) Information

Brand Name: VMA-SKREEN
Version or Model: 35071504
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 35071504
Company Name: BIOCHEMICAL DIAGNOSTICS INC

Primary DI Number: 00810042682283
Issuing Agency: GS1
Commercial Distribution End Date: January 10, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 028007698 *Terms of Use

Device Description: SODIUM CARBONATE REAGENT 10%, 60mL

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):	Yes
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?
60612	HVA/VMA/5HIAA 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 qquantitative measurement of homovanillic acid (HVA), vanillylmandelic acid (VMA) and 5-hydroxyindoleacetic acid (5HIAA) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CDF	Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin

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
No Device Sizes

Device Record Status

Public Device Record Key: 6f0c829c-d9b5-433e-97e6-c20add22dde7
Public Version Date: January 11, 2022
Public Version Number: 2
DI Record Publish Date: April 30, 2020