OneTouch Ping 023-049

GUDID 20353885011673

OneTouch Ping Blood Glucose Management System. Meter Remote

LifeScan Europe GmbH

Glucose analyser IVD, home-use

• Primary Device ID: 20353885011673
• NIH Device Record Key: 0e4551fa-cfcf-4733-8226-b103c06eba4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OneTouch Ping
• Version Model Number: 023-049
• Catalog Number: 023-049
• Company DUNS: 480240820
• Company Name: LifeScan Europe GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +1(877)937-7867
• Email: XX@XX.XX

Device Dimensions

• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge
• Needle Gauge: 28 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00353885011679 [Primary]
GS1	20353885011673 [Package]; Contains: 00353885011679; Package: Shipper case [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082590

FDA Product Code

• LZG: PUMP, INFUSION, INSULIN

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: 2019-07-26
• Device Publish Date: 2017-12-14

Devices Manufactured by LifeScan Europe GmbH

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• 20353885012618 - OneTouch Verio: 2022-09-08 OneTouch Verio Test Strips. For Blood Glucose testing with OneTouch Verio Family of meters. For in vitro diagnostic use. For sel
• 20353885012625 - OneTouch Ultra Plus Flex: 2022-09-08 OneTouch Ultra Plus Flex™ Blood Glucose Monitoring System
• 20353885012632 - OneTouch Ultra Plus: 2022-09-08 OneTouch Ultra® Plus strips work with OneTouch Ultra Plus Flex(TM) meter.
• 80353885012641 - OneTouch Ultra Plus: 2022-09-08 OneTouch Ultra Plus™ Level 3 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.
• 20353885012687 - OneTouch Ultra Plus: 2022-09-08 OneTouch Ultra Plus™ Level 4 Control Solution for Use with OneTouch Ultra Plus Flex™ Meter.
• 20353885012472 - OneTouch Verio Reflect: 2022-05-27 OneTouch Verio Reflect Blood Glucose Monitoring System. Starter Kit.