FANTABSTIC DANLEE ELECTRODE RESTING TAB (100 PER POUCH)

GUDID 00816310022997

DANLEE MEDICAL PRODUCTS, INC

Electrocardiographic electrode, single-use

• Primary Device ID: 00816310022997
• NIH Device Record Key: 82d8f5a9-7fcc-4c05-a3eb-4b92177407fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FANTABSTIC DANLEE ELECTRODE RESTING TAB (100 PER POUCH)
• Version Model Number: ED3000
• Company DUNS: 878130871
• Company Name: DANLEE MEDICAL PRODUCTS, INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816310022997 [Primary]
GS1	10816310022994 [Package]; Package: BOX [5 Units]; In Commercial Distribution
GS1	20816310022991 [Package]; Contains: 10816310022994; Package: CASE [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K931457

FDA Product Code

• DRX: Electrode, Electrocardiograph

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: 2020-07-01
• Device Publish Date: 2020-06-23

Devices Manufactured by DANLEE MEDICAL PRODUCTS, INC

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• 00816310023796 - DANLEE MEDICAL KIT: 2024-10-17 ECG PREP KIT (ZKIT) CONMED
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• 00816310023772 - DANLEE MEDICAL KIT: 2024-06-24 ECG PREP KIT (ZKIT) VERMED
• 00816310023758 - DANLEE MEDICAL KIT: 2024-02-29 ECG PREP KIT (ZKIT) AMBU R SERIES
• 00816310023765 - DANLEE MEDICAL KIT: 2024-02-29 ECG PREP KIT (ZKIT) AMBU R SERIES