Aquoral

Primary DI
10196852643216
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
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
047318115
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00196852643219Aquoral1968526432192023-07-27

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
00196852643219AquoralK Pharmaceuticals, LLCKEP2023-07-27