Telemetry Transmitter 115-029485-00

GUDID 06944904055343

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

Multiple-patient intensive/general healthcare physiologic monitoring system

• Primary Device ID: 06944904055343
• NIH Device Record Key: d50e32e6-1cda-4d60-856d-38a4936a540b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Telemetry Transmitter
• Version Model Number: TD-60
• Catalog Number: 115-029485-00
• 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: false
• 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	06944904055343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150632

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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-02-06
• Device Publish Date: 2015-10-23

On-Brand Devices [Telemetry Transmitter]

• 06944904055343: TD-60
• 06944904054650: 608M