AccessGUDID - DEVICE: PeraChek (00898021000242)

GUDID

Device Identifier (DI) Information

Brand Name: PeraChek
Version or Model: 1701-01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1701-01
Company Name: Angelini Pharma Inc.

Primary DI Number: 00898021000242
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078843940 *Terms of Use

Device Description: Reagent test strip for measuring the concentration of peracetic acid in dialyzer reprocessing.

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
MSY	Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
LIF	Dialyzer Reprocessing System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980164	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
Handling Environment Temperature: between 60 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 60 and 90 Degrees Fahrenheit
Special Storage Condition, Specify: Must be kept in the original bottle with the lid tightly closed. Do not remove dessicant pack.

Clinically Relevant Size

[?]

Size Type Text
Width: 0.2 Inch
Length: 3.25 Inch

Device Record Status

Public Device Record Key: e5e52977-ef04-4b6d-a861-2d86b449ef23
Public Version Date: February 15, 2023
Public Version Number: 4
DI Record Publish Date: May 23, 2017