Aquoral

Primary DI
00196852643219
Brand
Aquoral
Company
K Pharmaceuticals, LLC
Model
196852643219
Device description
Saliva substitue - protective oral spray
Published
2023-07-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KEPMEDIA, MOUNTING, OIL SOLUBLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEPMedia, Mounting, Oil SolublePathology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051812000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051812000TGO SPRAYLaboratoires Carilene S.A.S.2005-10-21LFD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196852643219PrimaryGS10
10196852643216Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196852643219001968526432191968526432190196852643219
1019685264321610196852643216

GMDN Terms#

Term, Definition table
TermDefinition
Medication spray bottleAn empty, flexible squeeze-container with a spray nozzle used to deliver medication in an atomized form, e.g., nasal spray. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(630)319-0778info@kpharmaceutical.com

Regulatory Flags#

DUNS number
047318115
Device count
2
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10196852643216Aquoral1968526432192023-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06945326839542Disposable Infusion Bag for Parenteral NutritionBeijing L&Z Medical Technology Development Co., LtdKEP2024-09-27
10196852643216AquoralK Pharmaceuticals, LLCKEP2023-07-27