Covidien

GUDID 30817357020848

Covidien Disposable 6 Lead System For Use with GE Apex™Pro FH Telemetry System-Direct Connect

HYGIA HEALTH SERVICES, INC.

Electrocardiographic lead set, reprocessed

• Primary Device ID: 30817357020848
• NIH Device Record Key: b6c386bf-d72c-40ae-8797-631d4d1bcea6
• Commercial Distribution Discontinuation: 2019-07-10
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Covidien
• Version Model Number: 33126
• Company DUNS: 177939027
• Company Name: HYGIA HEALTH SERVICES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10817357020844 [Primary]
GS1	30817357020848 [Package]; Contains: 10817357020844; Package: Box [10 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution
GS1	50817357020842 [Package]; Package: Case [10 Units]; Discontinued: 2021-03-19; Not in Commercial Distribution

FDA Product Code

• IKD: Cable, Electrode

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: 2021-03-19
• Device Publish Date: 2016-09-30

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