Schiller ECG wire set 2.410308

GUDID 07613365000344

ECG 5-wire set AHA clip 1.2 m radiolucent

Schiller AG

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable

• Primary Device ID: 07613365000344
• NIH Device Record Key: 6cd630c4-451f-43fd-9a14-54b90c9cc02b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Schiller ECG wire set
• Version Model Number: 2.410308
• Catalog Number: 2.410308
• Company DUNS: 480868538
• Company Name: Schiller AG
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch
• Phone: +41417664242
• Email: info@schiller.ch

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613365000344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012226

FDA Product Code

• DSA: Cable, Transducer And Electrode, Patient, (Including Connector)

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: 2020-02-10
• Device Publish Date: 2016-09-20

On-Brand Devices [Schiller ECG wire set]

• 07613365001716: ECG 5-wire set AHA clip 1.8 m
• 07613365000412: ECG 10-wire set AHA LP clip 1.2 m
• 07613365000382: ECG 5-wire set AHA clip 1.2 m
• 07613365000368: ECG 5-wire set AHA clip 1.2 m HF protected
• 07613365000351: ECG 10-wire set AHA clip 1.2 m radiolucent
• 07613365000344: ECG 5-wire set AHA clip 1.2 m radiolucent
• 07613365000337: ECG 10-wire set IEC clip 1.2 m radiolucent
• 07613365000320: ECG 10-wire set IEC clip 1.2 m
• 07613365000290: ECG 5-wire set IEC clip 1.2 m radiolucent
• 07613365003659: LS, RAL 7032, 1,0M, x5 IEC