AccessGUDID - DEVICE: SULFOLYSER (04987562422975)

GUDID

Device Identifier (DI) Information

Brand Name: SULFOLYSER
Version or Model: BJ350971
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYSMEX CORPORATION

Primary DI Number: 04987562422975
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 690664461 *Terms of Use

Device Description: SULFOLYSER is a reagent for the automated determination of hemoglobin concentration of blood with Sysmex automated hematology analyzers.

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:	No
Prescription Use (Rx):	Yes
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?
55875	Total haemoglobin (totHb) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of total haemoglobin (totHb) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GGK	Products, Red-Cell Lysing Products

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 1 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.5 Liter

Device Record Status

Public Device Record Key: 05d2ab06-7085-421e-a985-be0b3460266f
Public Version Date: December 08, 2022
Public Version Number: 1
DI Record Publish Date: November 30, 2022