CONTOUR® NEXT 83624826

GUDID 50301937315010

Control Solution - Level 1. 1 x 2.5 mL.

ASCENSIA DIABETES CARE US INC.

Glucose monitoring system IVD, home-use

• Primary Device ID: 50301937315010
• NIH Device Record Key: 1b0add37-248b-4793-b13c-160612f45feb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONTOUR® NEXT
• Version Model Number: 7315
• Catalog Number: 83624826
• Company DUNS: 080028910
• Company Name: ASCENSIA DIABETES CARE US 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: false
• 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: true
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com
• Phone: 18003488100
• Email: support@contournext.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.
• Storage Environment Temperature: Between 48 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Do not use after expiration date.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00301937315015 [Package]; Contains: 10301937315012; Package: carton [1 Units]; In Commercial Distribution
NDC/NHRIC	0193-7315-01 [Secondary]
GS1	10301937315012 [Primary]
GS1	40301937315013 [Package]; Contains: 00301937315015; Package: in.shipper/sm.case [12 Units]; In Commercial Distribution
GS1	50301937315010 [Package]; Contains: 40301937315013; Package: out.shipper/lg.case [32 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121190

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2024-11-06
• Device Publish Date: 2016-09-16

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