DANLEE MEDICAL KIT D022S5AB-1

GUDID 00816310023819

ECG PREP KIT (ZKIT) AMBU R SERIES

DANLEE MEDICAL PRODUCTS, INC

Electrocardiographic long-term ambulatory recording support kit

• Primary Device ID: 00816310023819
• NIH Device Record Key: 0711c964-f160-4c46-9c2c-8701d028c5b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DANLEE MEDICAL KIT
• Version Model Number: D022S5AB-1
• Catalog Number: D022S5AB-1
• Company DUNS: 878130871
• Company Name: DANLEE MEDICAL PRODUCTS, 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 50 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816310023819 [Primary]

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: 2024-11-07
• Device Publish Date: 2024-10-30

On-Brand Devices [DANLEE MEDICAL KIT]

• 00816310022638: ECG PREP KIT (ZKIT)
• 00816310022621: ECG PREP KIT (ZKIT)
• 00816310022614: ECG PREP KIT (ZKIT) MISC
• 00816310022607: ECG PREP KIT (ZKIT) MISC
• 00816310022591: ECG PREP KIT (ZKIT) VERMED
• 00816310022584: ECG PREP KIT (ZKIT) VERMED
• 00816310022577: ECG PREP KIT (ZKIT) CONMED
• 00816310022560: ECG PREP KIT (ZKIT) CONMED
• 00816310022553: ECG PREP KIT (ZKIT)
• 00816310022546: ECG PREP KIT (ZKIT) VERMED
• 00816310022539: ECG PREP KIT (ZKIT)
• 00816310022522: ECG PREP KIT (ZKIT)
• 00816310022515: ECG PREP KIT (ZKIT) VERMED
• 00816310022508: ECG PREP KIT (ZKIT) VERMED
• 00816310022492: ECG PREP KIT (ZKIT) VERMED
• 00816310022485: ECG PREP KIT (ZKIT) CONMED
• 00816310022478: ECG PREP KIT (ZKIT) CONMED
• 00816310022461: ECG PREP KIT (ZKIT) VERMED
• 00816310022454: ECG PREP KIT (ZKIT)
• 00816310022447: ECG PREP KIT (ZKIT) VERMED
• 00816310022430: ECG PREP KIT (ZKIT) VERMED
• 00816310022423: ECG PREP KIT (ZKIT) TAYLOR
• 00816310022409: ECG PREP KIT (ZKIT) VERMED
• 00816310022393: ECG PREP KIT (ZKIT) VERMED
• 00816310022386: ECG PREP KIT (ZKIT) VERMED
• 00816310022379: ECG PREP KIT (ZKIT) CONMED
• 00816310022362: ECG PREP KIT (ZKIT) VERMED
• 00816310022355: ECG PREP KIT (ZKIT) CONMED
• 00816310022331: ECG PREP KIT (ZKIT)
• 00816310022324: ECG PREP KIT (ZKIT)
• 00816310022317: ECG PREP KIT (ZKIT) NIKOMED
• 00816310022294: ECG PREP KIT (ZKIT) 3M
• 00816310022287: ECG PREP KIT (ZKIT) CONMED
• 00816310022270: ECG PREP KIT (ZKIT) CONMED
• 00816310022263: ECG PREP KIT (ZKIT) VERMED
• 00816310022256: ECG PREP KIT (ZKIT) VERMED
• 00816310022249: ECG PREP KIT (ZKIT) VERMED
• 00816310022232: ECG PREP KIT (ZKIT) 3M
• 00816310022225: ECG PREP KIT (ZKIT) MISC
• 00816310022218: ECG PREP KIT (ZKIT) CONMED
• 00816310022201: ECG PREP KIT (ZKIT) COVIDIEN/KENDALL
• 00816310022195: ECG PREP KIT (ZKIT) CONMED
• 00816310022188: ECG PREP KIT (ZKIT) CONMED
• 00816310022171: ECG PREP KIT (ZKIT) CONMED
• 00816310022164: ECG PREP KIT (ZKIT) CONMED
• 00816310022157: ECG PREP KIT (ZKIT) CONMED
• 00816310022133: ECG PREP KIT (ZKIT) CONMED
• 00816310022126: ECG PREP KIT (ZKIT) CONMED
• 00816310022119: ECG PREP KIT (ZKIT) VERMED
• 00816310022102: ECG PREP KIT (ZKIT) VERMED