DTPM PV993240

GUDID 26973471968781

3 mL of Inactivated Transport Medium in screw-cap tube, with swab

Shenzhen Dakewe Bio-engineering Co., Ltd

Oral/upper respiratory tract specimen collection kit

• Primary Device ID: 26973471968781
• NIH Device Record Key: 37a5a878-ceab-4846-8f65-25d79a09f20e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTPM
• Version Model Number: ITMNO
• Catalog Number: PV993240
• Company DUNS: 543029175
• Company Name: Shenzhen Dakewe Bio-engineering Co., Ltd
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06973471968763 [Previous]
GS1	06973471968787 [Unit of Use]
GS1	16973471968784 [Primary]
GS1	26973471968781 [Package]; Contains: 16973471968784; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220059

FDA Product Code

• QBD: Microbial Nucleic Acid Storage And Stabilization Device

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-17
• Device Publish Date: 2024-06-07

On-Brand Devices [DTPM]

• 06973471968763: 3 mL of Inactivated Transport Medium in screw-cap tube, with nasopharyngeal swabs and oropharyng
• 26973471968781: 3 mL of Inactivated Transport Medium in screw-cap tube, with swab