Assure® Slide Pill Swallowing Aid forte

GUDID 20015482100029

Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100025 is used as the assigned UDI for the Class I device.)

ARKRAY USA, INC.

Pill swallowing solution

• Primary Device ID: 20015482100029
• NIH Device Record Key: 8023219d-6f53-4228-9636-04bd95a3d255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Assure® Slide Pill Swallowing Aid forte
• Version Model Number: 1000002
• Company DUNS: 008171162
• Company Name: ARKRAY USA, INC.
• Device Count: 1
• 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: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx
• Phone: 800-818-8877
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 35 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00015482100025 [Primary]
GS1	10015482100022 [Package]; Contains: 00015482100025; Package: Case Pack [4 Units]; In Commercial Distribution
GS1	20015482100029 [Package]; Contains: 10015482100022; Package: Master Shipper [24 Units]; In Commercial Distribution

FDA Product Code

• NXB: Dispenser, Solid Medication

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-23
• Device Publish Date: 2018-12-28

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