SMARTMETER

GUDID 36945630120429

Sterilance Medical (Suzhou) Inc.

Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable Manual blood lancing device, reusable

• Primary Device ID: 36945630120429
• NIH Device Record Key: 08872c3d-b6e7-461d-8e4b-1b319fcc56dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMARTMETER
• Version Model Number: LDE4
• Company DUNS: 554434897
• Company Name: Sterilance Medical (Suzhou) Inc.
• 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945630120428 [Primary]
GS1	36945630120429 [Package]; Contains: 06945630120428; Package: [100 Units]; In Commercial Distribution

FDA Product Code

• QRL: Multiple Use Blood Lancet For Single Patient Use Only

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-08
• Device Publish Date: 2023-07-31

Devices Manufactured by Sterilance Medical (Suzhou) Inc.

• 26945630125779 - PRESS DISPOSABLE SAFETY LANCET: 2024-05-09
• 36945630125752 - EXALANCE LDE4 Lancing Device: 2024-05-02
• 06945630125522 - STERiLANCE SteriHeel Plus Heel Incision Safety Lancet: 2024-04-17
• 26945630125120 - Disposable Safety Lancet Press2: 2024-04-08
• 36945630121808 - neoheel: 2024-02-16
• 36945630121815 - neoheel: 2024-02-16
• 06945630121821 - neoheel: 2024-02-16
• 36945630124106 - neoheel: 2024-02-16