DIXIE

GUDID 00697038425037

HONSUN (NANTONG) CO.,LTD

Aneroid manual sphygmomanometer Aneroid manual sphygmomanometer

• Primary Device ID: 00697038425037
• NIH Device Record Key: 65b4a1e2-da39-4802-b6dc-3b35b586d39e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIXIE
• Version Model Number: HS-50D
• Company DUNS: 543364560
• Company Name: HONSUN (NANTONG) 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00697038425037 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092245

FDA Product Code

• DXQ: Blood Pressure Cuff

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-11-22

On-Brand Devices [DIXIE]

• 00697038425211: ZHE920PK
• 00697038425204: ZHE920PUR
• 00697038425105: 143401BK
• 00697038425099: HS-20A
• 00697038425082: HS-20A
• 00697038425075: HS-20A
• 00697038425068: HS-20A
• 00697038425051: HS-50D
• 00697038425044: HS-50D
• 00697038425037: HS-50D
• 00697038425020: HS-50D
• 00697038425013: 422208PUR
• 00697038425006: 422208PK