TEL-100 waterproof case(3lead AHA SNAP)

GUDID 06944904086859

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Single-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 06944904086859
• NIH Device Record Key: eaf0072e-85a1-4fd8-8c68-fa14e39c9368
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TEL-100 waterproof case(3lead AHA SNAP)
• Version Model Number: 115-010667-00
• Company DUNS: 654671304
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06944904086859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162607

FDA Product Code

• MSX: System, Network And Communication, Physiological Monitors

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: 2020-05-08
• Device Publish Date: 2020-04-30

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