ALPHAMED

GUDID 06953825905835

Shenzhen Urion Technology Co., Ltd

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06953825905835
• NIH Device Record Key: 89d8542e-d4a4-46a9-b30a-afea4e571423
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALPHAMED
• Version Model Number: U60B
• Company DUNS: 421294358
• Company Name: Shenzhen Urion Technology 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06953825905835 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141683

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

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: 2022-04-27
• Device Publish Date: 2022-04-19

On-Brand Devices [ALPHAMED]

• 06953825902766: U60EH
• 06953825902759: U60CH
• 06953825902742: U80R
• 06953825902735: U80B
• 06953825902728: U80EH
• 06953825902179: U80B
• 06953825901981: U80BH
• 06953825901974: U80B
• 06953825901967: U80A
• 06953825901950: U80AH
• 06953825901943: U60AH
• 06953825901936: U60A
• 06953825905019: U81M
• 06953825909031: HET-R171
• 06953825903787: U80X
• 06953825903831: U82RH
• 06953825904043: UFR102
• 06953825904036: UFR109
• 06953825904029: UFR105
• 06953825904012: UFR101
• 06953825903992: UFR103
• 06953825903985: UFR106
• 06953825904241: U62I
• 06953825904234: U85H
• 06953825904227: U81RH
• 06953825904210: U82NH
• 06953825904203: U81NH
• 06953825904197: U80N
• 06953825904395: U81Y
• 06953825904371: U85H
• 06953825907051: U80Y
• 06953825907044: U81RH
• 06953825907563: UFR118
• 06953825907358: U80EH
• 06953825906108: U87E
• 06953825909437: U81D
• 06953825909444: U81Q
• 06953825910105: U815
• 06953825905415: U63I
• 06953825905408: U83H
• 06953825905392: U80H
• 06953825905521: U82E
• 06953825905514: U81E
• 06953825905750: U80E
• 06953825905743: U81K
• 06953825905835: U60B
• 06953825905828: U82W
• 06953825905811: U81V
• 06953825905804: U81CH
• 06953825905866: U60E