Allheart

GUDID 00697038425297

HONSUN (NANTONG) CO.,LTD

Aneroid manual sphygmomanometer

• Primary Device ID: 00697038425297
• NIH Device Record Key: ed45b24b-258e-43ce-b264-61ca4d1c7aca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allheart
• Version Model Number: HS-50B
• Company DUNS: 543364560
• Company Name: HONSUN (NANTONG) CO.,LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• 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	00697038425297 [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: 2018-02-03

On-Brand Devices [Allheart ]

• 00697038425310: HS-20A
• 00697038425297: HS-50B
• 20697038425314: HS-20A