AccessGUDID - DEVICE: Serim® GUARDIAN™ Bicarb pH II Test Strips (M1745116A1)

GUDID

Device Identifier (DI) Information

Brand Name: Serim® GUARDIAN™ Bicarb pH II Test Strips
Version or Model: 5116A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5116A
Company Name: SERIM RESEARCH CORPORATION

Primary DI Number: M1745116A1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 605151018 *Terms of Use

Device Description: Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems.

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?
35001	Multi-parameter device tester	A battery-powered electronic device designed to measure two or more parameters (e.g., temperature, conductivity, pressure, pH, flow) to calibrate or test a medical device (e.g., haemodialysis equipment, anaesthesia machine, suction system, ophthalmic laser). It typically consists of a hand-held electronic box with appropriate connections and a digital display; dedicated measuring devices (e.g., probe, sensor, electrode, buffer solution) are typically included. It is not dedicated to a specific clinical discipline and is intended to be used by a professional in a professional setting (e.g., clinical engineering).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNV	Strip, Dialysate Ph Indicator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K945491	000

Device Exempt from Premarket Submission: No 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 15 and 30 Degrees Celsius
Handling Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f281f04b-6472-4e0e-8e69-c3856cea7091
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 19, 2016