FDA.reportPublic FDA data

Assure® Slide Pill Swallowing Aid zero

Primary DI
00015482100032
Brand
Assure® Slide Pill Swallowing Aid zero
Company
Arkray USA, Inc.
Model
1000003
Device description
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.)
Published
2018-12-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NXBDispenser, Solid Medication

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXBDispenser, Solid MedicationPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10015482100039PackageGS14Not in Commercial Distribution
20015482100036PackageGS124Not in Commercial Distribution
00015482100032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1001548210003910015482100039
2001548210003620015482100036
00015482100032000154821000320154821000320015482100032

GMDN Terms#

Term, Definition table
TermDefinition
Pill swallowing lubricantA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
800-818-8877xxx@xxx.xxx

Regulatory Flags#

DUNS number
008171162
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00015482000011ARK Care®Version 2.5.3.2016-09-23
00015482100025Assure® Slide Pill Swallowing Aid forte10000022018-12-28
00015482102913ASSURE® ID Insulin 1cc Safety Syringe2102912016-09-23
00015482102951ASSURE® ID Insulin 0.5cc Safety Syringe2102952016-09-23
00015482104658AUTION MAX™ AX-4060 Analyzer1005262025-11-07
00015482129743AUTION™ MAX AX-4022 Analyzer1029742017-02-03
00015482230296TechLITE PEN NEEDLES2301292016-09-23
00015482230326TechLITE Pen Needle 4mm x 32g Sample 10's2340322018-02-26
00015482230999TechLITE PEN NEEDLES2309292016-09-23
00015482232290TechLITE PEN NEEDLES2321292016-09-23
00015482232993TechLITE PEN NEEDLES2329292016-09-23
00015482234232TechLITE PLUS PEN NEEDLES2342322024-03-11
00015482234324TechLITE PEN NEEDLES2341322016-09-23
00015482234928TechLITE PEN NEEDLES2349322016-09-23
00015482235314TechLITE PEN NEEDLES2351312019-05-14
00015482235918TechLITE PEN NEEDLES2359312016-09-23
00015482236311TechLITE PEN NEEDLES2361312016-09-23
00015482236328TechLITE PEN NEEDLES2361322016-09-23
00015482238315TechLITE PEN NEEDLES2381312016-09-23
00015482238322TechLITE PEN NEEDLES2381322016-09-23

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Primary DI, Brand, Company table
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00194346678921EquateDrive Devilbiss HealthcareNXB2026-03-09
00194346615155EquateDrive Devilbiss HealthcareNXB2026-01-20
30194346615156EquateCOMPASS HEALTH BRANDS CORP.NXB2026-01-20
00850068074228TenoviTenovi Co.NXB2026-01-02
00194346134694EquateWAL-MART STORES, INC.NXB2025-11-14
00850068074020TenoviTenovi Co.NXB2025-09-08
00085006807402TenoviTenovi Co.NXB2025-08-29
00850068074525TenoviTenovi Co.NXB2025-08-29
00076855700600ApexDrive Devilbiss HealthcareNXB2025-08-28
40076855700608ApexCOMPASS HEALTH BRANDS CORP.NXB2025-08-28
10827989000527Health Care Logistics, Inc®Health Care Logistics, Inc.NXB2025-03-13
10827989000633Health Care Logistics, Inc®Health Care Logistics, Inc.NXB2025-03-13
10827989000640Health Care Logistics, Inc®Health Care Logistics, Inc.NXB2025-03-13
10827989004037Health Care Logistics, Inc®Health Care Logistics, Inc.NXB2025-03-13
00041520865816ApexDrive Devilbiss HealthcareNXB2024-12-09
00635515992764ApexDrive Devilbiss HealthcareNXB2024-12-09
30041520865817ApexCOMPASS HEALTH BRANDS CORP.NXB2024-12-09
30635515992765ApexCOMPASS HEALTH BRANDS CORP.NXB2024-12-09
00087701190568ApexDrive Devilbiss HealthcareNXB2024-11-14
00087701190599ApexDrive Devilbiss HealthcareNXB2024-11-14
20087701190562ApexCOMPASS HEALTH BRANDS CORP.NXB2024-11-14
20087701190593ApexCOMPASS HEALTH BRANDS CORP.NXB2024-11-14
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