N/A

GUDID 16970784670007

wenzhou dongfang medical instrument co.,ltd

Blood pressure cuff, reusable

• Primary Device ID: 16970784670007
• NIH Device Record Key: ee09fd3a-7628-4a2e-b224-11b232e00928
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: KT-A05
• Company DUNS: 529870243
• Company Name: wenzhou dongfang medical instrument 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16970784670007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081951

FDA Product Code

• DXQ: Blood Pressure Cuff

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: 2022-01-07
• Device Publish Date: 2021-12-30

On-Brand Devices [N/A]

• 16970784670007: KT-A05
• 16970784670014: KT-A02
• 06970784670048: KT-A02