AccessGUDID - DEVICE: N/A (00819398023191)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: R201
Commercial Distribution Status: In Commercial Distribution
Catalog Number: R201
Company Name: HARDY DIAGNOSTICS

Primary DI Number: 00819398023191
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 039981550 *Terms of Use

Device Description: Phosphate Buffered Saline (PBS), 1.0ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20 Hardy Diagnostics Phosphate Buffered Saline (pH of 7.5) is recommended as a diluent for quantitative culturing or as a rinsing agent in microbiological, immunological, histological and molecular testing procedures.

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?
58208	Buffered sample diluent IVD, manual	A buffered solution intended to be used for the manual (non-automated) dilution of samples, either pre-analytically or during the processing, staining and/or testing of clinical laboratory specimens.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LIB	Device, General Purpose, Microbiology, Diagnostic

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: ecfbb24b-df69-4631-bac6-481701447439
Public Version Date: June 12, 2020
Public Version Number: 1
DI Record Publish Date: June 04, 2020