Dakewe 3983161

GUDID 06973471960590

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

Shenzhen Dakewe Bio-engineering Co., Ltd

Oral/upper respiratory tract specimen collection kit

• Primary Device ID: 06973471960590
• NIH Device Record Key: 7dc93aec-9d39-4b58-81f2-57778a462980
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dakewe
• Version Model Number: ITMT
• Catalog Number: 3983161
• Company DUNS: 543029175
• Company Name: Shenzhen Dakewe Bio-engineering Co., Ltd
• Device Count: 1
• 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	06973471960590 [Primary]
GS1	16973471960597 [Package]; 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: 2023-03-01
• Device Publish Date: 2023-02-21

On-Brand Devices [Dakewe]

• 06973471960613: 3 mL of Inactivated Transport Medium in screw-cap tube, with mid-turbinate swabs. 50 tests per p
• 06973471960606: 2 mL of Inactivated Transport Medium in screw-cap tube, with mid-turbinate swabs. 50 tests per p
• 06973471960590: 1 mL of Inactivated Transport Medium in screw-cap tube, with mid-turbinate swabs. 50 tests per p
• 06973471960583: 3 mL of Inactivated Transport Medium in screw-cap tube, with oropharyngeal swabs. 50 tests per p
• 06973471960576: 2 mL of Inactivated Transport Medium in screw-cap tube, with oropharyngeal swabs. 50 tests per p
• 06973471960569: 1 mL of Inactivated Transport Medium in screw-cap tube, with oropharyngeal swabs. 50 tests per p
• 06973471960552: 3 mL of Inactivated Transport Medium in screw-cap tube, with nasopharyngeal swabs. 50 tests per
• 06973471960545: 2 mL of Inactivated Transport Medium in screw-cap tube, with nasopharyngeal swabs. 50 tests per
• 06973471960538: 1 mL of Inactivated Transport Medium in screw-cap tube, with nasopharyngeal swabs. 50 tests per
• 06973471960521: 3 mL of Inactivated Transport Medium in screw-cap tube. 50 tests per package.
• 06973471960514: 2 mL of Inactivated Transport Medium in screw-cap tube. 50 tests per package.
• 06973471960507: 1 mL of Inactivated Transport Medium in screw-cap tube. 50 tests per package.