Assure® Lance Safety Lancets

GUDID 10015482980181

Assure Lance Safety Lancets 28g 100's. Single-use disposable blood lancet should be used for assisted blood draws by healthcare providers or at healthcare provision sites. Dispose of used lancets in approved sharps container.

ARKRAY USA, INC.

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• Primary Device ID: 10015482980181
• NIH Device Record Key: f668ecdc-3f77-43d3-8db7-9133bca03e57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure® Lance Safety Lancets
• Version Model Number: 980128
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• Email: xxx@xxx.xxx
• Phone: 1-800-818-8877
• 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
• 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
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Handling Environment Temperature: Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482980184 [Primary]
GS1	10015482980181 [Package]; Contains: 00015482980184; Package: Shipper Carton [48 Units]; In Commercial Distribution
GS1	50015482980189 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222084

FDA Product Code

• FMK: Lancet, Blood

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: 2020-08-06
• Device Publish Date: 2018-09-24

On-Brand Devices [Assure® Lance Safety Lancets]

• 10015482980280: Assure Lance Safety Lancets 28g 200's. Single-use disposable blood lancet should be used for as
• 10015482980228: Assure Lance Safety Lancets 21g 200's. Single-use disposable blood lancet should be used for as
• 10015482980181: Assure Lance Safety Lancets 28g 100's. Single-use disposable blood lancet should be used for as
• 10015482983281: Assure Lance Safety Lancets 28g 30ct. Single-use disposable blood lancet should be used for ass
• 10015482981218: Assure Lance Safety Lancets 21g 100's. Single-use disposable blood lancet should be used for as
• 10015482980129: Assure Lance Safety Lancets 25g 100's. Single-use disposable blood lancet should be used for as