AccessGUDID - DEVICE: Epredia (00673693090513)

GUDID

Device Identifier (DI) Information

Brand Name: Epredia
Version or Model: Acetone High Purity
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9000-5
Company Name: RICHARD-ALLAN SCIENTIFIC COMPANY

Primary DI Number: 00673693090513
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 929504710 *Terms of Use

Device Description: Acetone is specifically designed for laboratory procedures. The product is a clear, colorless reagent that is highly quality controlled. Acetone is a known toxin. Ingestion may result in blindness or death. Precaution should be taken when handling Acetone. Protective gloves should be worn and work should be performed in a ventilated area. Acetone is a highly flammable product and must be stored in a flammable fire cabinet.

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?
55471	Acetone 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 acetone in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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: 5757b8e4-f33d-443b-852a-8cb4d9d88529
Public Version Date: August 05, 2024
Public Version Number: 1
DI Record Publish Date: July 28, 2024