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 ID20015482100029
NIH Device Record Key8023219d-6f53-4228-9636-04bd95a3d255
Commercial Distribution StatusIn Commercial Distribution
Brand NameAssure® Slide Pill Swallowing Aid forte
Version Model Number1000002
Company DUNS008171162
Company NameARKRAY USA, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx
Phone800-818-8877
Emailxxx@xxx.xxx

Operating and Storage Conditions

Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 35 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100015482100025 [Primary]
GS110015482100022 [Package]
Contains: 00015482100025
Package: Case Pack [4 Units]
In Commercial Distribution
GS120015482100029 [Package]
Contains: 10015482100022
Package: Master Shipper [24 Units]
In Commercial Distribution

FDA Product Code

NXBDispenser, Solid Medication

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-23
Device Publish Date2018-12-28

Devices Manufactured by ARKRAY USA, INC.

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00015482117344 - AUTION™ Sticks 9EB - Test Strips2024-12-10 AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following ana
00015482181550 - AUTION EYE™ Sheath Solution - 10L Bottle2024-12-10 AUTION EYE Sheath Solution is intended for in vitro diagnostic use with the AUTION EYE AI-4510 analyzer to identify formed parti
00015482181574 - AUTION EYE™ Control Solution H/L2024-12-10 AUTION EYE Control Solution H/L is intended for in vitro diagnostic use only for performing quality control procedures with the
00015482181598 - AUTION EYE™ Calibrator Focus/Calibrator2024-12-10 AUTION EYE Calibrator is intended for in vitro diagnostic use only for focusing and calibrating the AUTION EYE AI-4510.
00015482188627 - AUTION EYE™ AI-4510 Analyzer2024-12-10 The AUTION EYE AI-4510 Urine Particle Analysis System is a fully automated urine particle analyzer for in vitro diagnostic use.
14987486005299 - Concentrated Washing Solution 32024-12-10 A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated ins
00015482183103 - SPOTCHEM™ EZ Analyzer2024-05-31 Dry Chemistry Analyzer IVD, semi-automated

Trademark Results [Assure]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ASSURE
ASSURE
98452802 not registered Live/Pending
Aqua Horizon LLC
2024-03-16
ASSURE
ASSURE
98235302 not registered Live/Pending
Caris MPI, Inc.
2023-10-23
ASSURE
ASSURE
98144267 not registered Live/Pending
Superior Plastics Extrusion Co Inc
2023-08-22
ASSURE
ASSURE
97901492 not registered Live/Pending
Resilient Floor Covering Institute, Inc.
2023-04-21
ASSURE
ASSURE
97614385 not registered Live/Pending
PerkinElmer Health Sciences, Inc.
2022-09-30
ASSURE
ASSURE
97526467 not registered Live/Pending
Qualia Labs, Inc.
2022-07-29
ASSURE
ASSURE
97448887 not registered Live/Pending
PRESTIGE MARKETING, LTD.
2022-06-08
ASSURE
ASSURE
90315893 not registered Live/Pending
LSI Wallcovering, Inc.
2020-11-12
ASSURE
ASSURE
90238064 not registered Live/Pending
Azure Biotech, Inc.
2020-10-06
ASSURE
ASSURE
90030227 not registered Live/Pending
Zep IP Holding LLC
2020-07-01
ASSURE
ASSURE
88908804 not registered Live/Pending
Syed Doha, Inc.
2020-05-10
ASSURE
ASSURE
88837750 not registered Live/Pending
West Affum Holdings Corp.
2020-03-17

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