Dakewe

Basic Information

• Brand Name: Dakewe
• Primary DI: 06973471960590
• Version / Model: ITMT
• Catalog Number: 3983161
• 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: 2023-02-21
• Public Version: 2
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: 7dc93aec-9d39-4b58-81f2-57778a462980

Device Description

1 mL of Inactivated Transport Medium in screw-cap tube, with mid-turbinate swabs. 50 tests per package.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QBD	Microbial Nucleic Acid Storage And Stabilization Device	Microbiology	866.2950	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61164	Oral/upper respiratory tract specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06973471960590	GS1
Package	16973471960597	GS1		12	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K220059	000