AccessGUDID - DEVICE: Myron L® Company (00857744006108)

GUDID

Device Identifier (DI) Information

Brand Name: Myron L® Company
Version or Model: Solution, NaCl, 14.0 Millimhos, 2 Ounces
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NACL-14.02OZ
Company Name: MYRON L COMPANY

Primary DI Number: 00857744006108
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064468689 *Terms of Use

Device Description: NaCl Standard Solution is offered to calibrate instruments that measure any sample that is predominately NaCI (sodium chloride), such as Dialysate. It’s FDA Product Code is FKH: Solution, Test Standard, Conductivity, Dialysis.

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):	Yes
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?
47678	Haemodialysis conductivity standard solution	A salt solution, typically salt dissolved in deionized/purified water, used to calibrate conductivity meters used to test the conductivity of dialysate, dialysate concentrate, and water treatment systems used with haemodialysis delivery systems. The solution is typically available in sealed plastic bottles and in a range of values and accuracies. It may be available over-the-counter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FKH	Solution-Test Standard-Conductivity, Dialysis

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
Special Storage Condition, Specify: Do Not Freeze
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Fluid Ounce

Device Record Status

Public Device Record Key: 000c7ecf-92b8-4d61-ab79-1a55f7ef68ce
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016