TechLITE® Lancets, 28g

GUDID 00015482880187

TechLITE Lancets 28g 100's. The lancet is intended for capillary blood sampling.

ARKRAY USA, INC.

Blood lancing device tip

• Primary Device ID: 00015482880187
• NIH Device Record Key: 56f1e922-cb6f-4993-a549-f97eb0d277bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TechLITE® Lancets, 28g
• Version Model Number: 880128
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 100
• 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: 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: true

Customer Support Contacts

• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx
• Phone: 1-800-566-8558
• Email: xxx@xxx.xxx

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482880187 [Primary]
GS1	10015482880184 [Package]; Package: Case Pack [24 Units]; In Commercial Distribution
GS1	20015482880181 [Package]; Contains: 10015482880184; Package: Master Shipper [12 Units]; In Commercial Distribution
GS1	50015482880182 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220475

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-27
• Device Publish Date: 2018-09-24

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• 00015482771058 - SPOTCHEM™ II BUN: 2024-05-31 Strip description for the invitro quantitative determination of blood urea nitrogen in human plasma from whole blood samples
• 00015482771065 - SPOTCHEM™ II Total Bilirubin: 2024-05-31 Strip description for the invitro quantitative determination of total bilirubin concentration in human plasma from whole blood s
• 00015482771072 - SPOTCHEM™ II Calcium: 2024-05-31 Strip description for the invitro quantitative determination of calcium concentration in human plasma from whole blood samples