AccessGUDID - DEVICE: Serim® GUARDIAN™ Residual Formaldehyde Test Strips (M17451121)

GUDID

Device Identifier (DI) Information

Brand Name: Serim® GUARDIAN™ Residual Formaldehyde Test Strips
Version or Model: 5112
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5112
Company Name: SERIM RESEARCH CORPORATION

Primary DI Number: M17451121
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 605151018 *Terms of Use

Device Description: Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldehyde remaining after rinsing dialyzers or dialysate lines prior to use in hemodialysis.

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
LIF	Dialyzer Reprocessing System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K914123	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 2 and 7 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: 0498db39-1802-49e3-a0c9-7db0e58b5f61
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 08, 2016