Electronic Blood Pressure Monitor

GUDID 06948423802778

Shenzhen Pango Electronic Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 06948423802778
• NIH Device Record Key: 67c364a4-b082-431a-8e03-4be5a53b96ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electronic Blood Pressure Monitor
• Version Model Number: PG-800A25
• Company DUNS: 529222127
• Company Name: Shenzhen Pango Electronic 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: false
• 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	06948423802778 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161845

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-07-06

On-Brand Devices [Electronic Blood Pressure Monitor]

• 06948423807520: PG-800B43
• 06948423807513: PG-800B42
• 06948423806769: PG-800B23
• 06948423806424: PG-800B27
• 06948423806417: PG-800B37
• 06948423806400: PG-800B36
• 06948423806394: PG-800B26
• 06948423806387: PG-800A37
• 06948423806059: PG-800A36
• 06948423806042: PG-800B35
• 06948423806035: PG-800B32
• 06948423806028: PG-800A35
• 06948423806011: PG-800A33
• 06948423806004: PG-800A32
• 06948423805830: PG-800B22
• 06948423805632: PG-800B33
• 06948423805281: PG-800A31
• 06948423804598: PG-800B31
• 06948423802792: PG-800A27
• 06948423802778: PG-800A25
• 06948423800583: PG-800A15
• 06948423800576: PG-800A12
• 06948423800569: PG-800A11
• 06948423800552: PG-800A9
• 06948423800545: PG-800A8
• 06948423800538: PG-800A7D
• 06948423800521: PG-800A7
• 06948423800514: PG-800A6-2
• 06948423800507: PG-800A6-1
• 06948423800491: PG-800A6D
• 06948423800484: PG-800A6
• 06948423800477: PG-800A5
• 06948423800460: PG-800A4D
• 06948423800453: PG-800A4
• 06948423800446: PG-800A3
• 06948423800439: PG-800AD-1
• 06948423800422: PG-800A-1
• 06948423800415: PG-800AD
• 06948423800408: PG-800A
• 06948423800194: PG-800B15
• 06948423800187: PG-800B12
• 06948423800170: PG-800B11
• 06948423800163: PG-800B10
• 06948423800156: PG-800B9
• 06948423800149: PG-800B8
• 06948423800132: PG-800B7
• 06948423800125: PG-800B6-2
• 06948423800118: PG-800B6-1
• 06948423800101: PG-800B6D
• 06948423800095: PG-800B6