AccessGUDID - DEVICE: Serim® GUARDIAN™ HiSENSE™ Test Kit (M17451091)

GUDID

Device Identifier (DI) Information

Brand Name: Serim® GUARDIAN™ HiSENSE™ Test Kit
Version or Model: 5109
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5109
Company Name: SERIM RESEARCH CORPORATION

Primary DI Number: M17451091
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 605151018 *Terms of Use

Device Description: The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.

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?
62445	Haemodialysis dialysate water chlorine test kit	A collection of reagents and other associated materials intended to be used to rapidly indicate, through colour change, the concentration of total chlorine in water used to prepare dialysate solution for haemodialysis. It includes test tubes, a colorimetric reagent (e.g., DPD, potassium iodide) which produces a colour change upon reaction with chlorine/chloramine, and a visual standard for colour comparison. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIP	Subsystem, Water Purification

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K952215	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: 478bd335-3a6a-471b-aaec-dba9f403ed61
Public Version Date: February 09, 2026
Public Version Number: 4
DI Record Publish Date: September 19, 2016