Assure Slide Pill Swallowing Aid is for people with swallowing difficulties, a gell that helps to swallow tablets, capsules and powders. (Primary UPC# 015482100032 is used as the assigned UDI for the Class I device.)
Assure® Slide Pill Swallowing Aid zero - 1000003
Device Description
A substance intended to be directly administered in the oral cavity, or combined with a tablet/capsule prior to oral administration, to facilitate pill deglutition (swallowing). It is available in spray or gel form and formulated to function as a lubricant (e.g., contains glycerol). After application, this device cannot be reused.
Environmental Conditions
- 77.00
- 35.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NXB
Device Name: Dispenser, Solid Medication
Device Class: 1
Physical State: The device is designed for primarily oral dosage forms of medication.
Definition: A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication.
Submission Type ID: 4
Review Panel: HO
Review Code: N/A
Technical Method: Y
Gmp Exempt Flag: This device can function independently, with components or within a system.
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: dependent on drug indication.
Regulation Number: 890.5050
Third Party Flag: N
Medical Specialty: PM
Device IdentifiersDevice Id: 20015482100036
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10015482100039
Package Quantity: 24
Package Discontinue Date: 9/19/2023 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Master Shipper
Device Id: 10015482100039
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00015482100032
Package Quantity: 4
Package Discontinue Date: 9/19/2023 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Case Pack
Device Id: 00015482100032
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
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