AccessGUDID - DEVICE: BlueMount™ (00819398027182)

GUDID

Device Identifier (DI) Information

Brand Name: BlueMount™
Version or Model: Z137
Commercial Distribution Status: In Commercial Distribution
Catalog Number: Z137
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398027182
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: BlueMount™, permanent fungal stain, lactophenol cotton blue with PVA, 15ml each A permanent slide mounting media for mycology specimens that contains the stain lactophenol cotton blue. Produces a long lasting permanently stained slide. Contains polyvinyl alcohol (PVA) that will dry and set up hard to create a perfectly preserved slide.

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?
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	Discs, Strips And Reagents, Microorganism Differentiation

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 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 102441c9-c3c1-4313-a6f6-937fb731c1bd
Public Version Date: June 19, 2020
Public Version Number: 1
DI Record Publish Date: June 11, 2020