Biosci™

Basic Information

• Brand Name: Biosci™
• Primary DI: 06973471960712
• Version / Model: MSY
• Company Name: Shenzhen Dakewe Bio-engineering Co., Ltd
• Labeler DUNS: 543029175
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-08
• Public Version: 1
• Public Version Date: 2022-12-16
• Public Version Status: New
• Public Device Record Key: 5a2370ca-850b-4ae1-9033-68a21cb1ccca

Device Description

3 ml of 0.85% Biosci™ Sterile Normal Saline in screw-cap tube, with oropharyngeal swab.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QMC	Transport Medium, Notified Per The Vtm Guidance	Microbiology	866.2390	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57927	General tissue specimen container IVD, fixative/saline	A covered receptacle (single- or multiple-compartment) containing a tissue fixation or preservation solution [e.g., formalin, saline] 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 tissue specimen sampling/excision devices. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06973471960712	GS1