cellQART®

Basic Information

• Brand Name: cellQART®
• Primary DI: 04260649291368
• Version / Model: cytoQART GYN (PAP) Filters
• Catalog Number: 968111
• Company Name: SABEU GmbH & Co. KG
• Labeler DUNS: 316894864
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-10-01
• Public Version: 1
• Public Version Date: 2021-10-11
• Public Version Status: New
• Public Device Record Key: fc2b1e3b-c829-43c3-ba28-846ac19a7cc8

Device Description

Fluid specimen concentration filter IVD

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KET	Filters, Cell Collection, Tissue Processing	Pathology	864.3010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65389	Fluid specimen concentration filter IVD	A screening receptacle intended to concentrate a fluid clinical specimen [e.g., serum, urine, cerebrospinal fluid (CSF)] by filtration prior to in vitro diagnostic investigation. It is in the form of a container (e.g., tube, multi-well reservoir) with a semi-permeable filtering membrane, whereby specimen suspension particles [e.g., tissue culture extracts, cells, antigens, antibodies, proteins, hormones, DNA, RNA, column eluates, salts] are retained in a recoverable sub-volume of the specimen after filtration (e.g., by centrifugation, or absorption). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	04260649291351	GS1
Primary	04260649291368	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: avoid direct sunlight