QudraView

Basic Information

• Brand Name: QudraView
• Primary DI: 06973166110033
• Version / Model: 100
• Company Name: CompAI Healthcare (Shenzhen) Co.,ltd
• Labeler DUNS: 554511443
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-03
• Public Version: 4
• Public Version Date: 2023-05-08
• Public Version Status: Update
• Public Device Record Key: c800bf68-9462-4d19-8111-77d1becee8c5

Device Description

Specimen Hold

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
NNI	Container, Specimen, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63838	General tissue specimen container IVD, no additive	A covered receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of tissue specimen (e.g., biopsy tissue) collected from any body part for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06973166110033	GS1
Package	16973166110030	GS1		10	In Commercial Distribution

Customer Contacts

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