AccessGUDID - DEVICE: SteriChek® Residual Peroxide Reagent Strips (00851575007075)

GUDID

Device Identifier (DI) Information

Brand Name: SteriChek® Residual Peroxide Reagent Strips
Version or Model: 811905
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 821971
Company Name: HACH COMPANY

Primary DI Number: 00851575007075
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1200
Labeler D-U-N-S® Number*: 091381780 *Terms of Use

Device Description: Reagent test strips used to measure the concentration of residual peroxide in rinse water from dialyzers and dialysate lines disinfected with peroxide/peracetic acid.

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?
58107	Hydrogen peroxide device disinfectant/sterilant test strip	A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of hydrogen peroxide (H2O2) in a device disinfectant and/or sterilant solution after preparation to ensure disinfectant/sterilant properties. It is used to prevent diluting the disinfectant/sterilant to a concentration that is lower than the manufacturer's recommended minimum effective concentration (MEC). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LIF	Dialyzer Reprocessing System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K974798	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
Special Storage Condition, Specify: Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.
Storage Environment Temperature: between 60 and 90 Degrees Fahrenheit
Handling Environment Temperature: between 60 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 3.25 Inch
Width: 0.2 Inch

Device Record Status

Public Device Record Key: f71b3028-cca5-4ef7-ab9e-2acecbecf54b
Public Version Date: September 12, 2018
Public Version Number: 4
DI Record Publish Date: September 23, 2016