FDA.reportPublic FDA data

AQUAGEL

Primary DI
10855683006019
Brand
AQUAGEL
Company
PARKER LABORATORIES INC
Model
LUBRICATING GEL
Catalog number
57-02-1
Device description
AQUAGEL LUBRICATING GEL 2 OZ TUBE
Published
2017-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMJLubricant, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K864556000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K864556000AQUALUBE(TM)Parker Laboratories, Inc.1986-12-01KMJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10855683006019PrimaryGS10
00855683006012Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085568300601910855683006019
00855683006012008556830060128556830060120855683006012

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive mediumA non-sterile substance intended to be used as a medium for the efficient transmission of electrical signals between an electrode and the body, and for the reduction of the isolation properties of the skin. It is typically in the form of a gel, paste, spray or cream and is usually used in electrocardiography, defibrillation and diathermy. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
973-276-9500customerservice@parkerlabs.com

Regulatory Flags#

DUNS number
002449593
Device count
100
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
00303410000012AquaflexULTRASOUND GEL PAD 04-92-8203112025-05-30
00303410000029AquaflexULTRASOUND GEL PAD 04-90-8203112024-08-28
00303410000036AquaflexULTRASOUND GEL PAD 04-95-8203112024-11-20
00855683006579Delphinus Sequr™ Breast Interface99-176-7809622023-01-24
10855683006576Delphinus Sequr™ Breast Interface99-176-7809622023-01-24
20855683006023STERILE AQUASONICULTRASOUND TRANSMISSION GEL01-01-42016-12-19
00855683006005STERILE AQUASONICULTRASOUND TRANSMISSION GEL01-012016-12-19
10303410000019AquaflexULTRASOUND GEL PAD 04-92-8203112025-05-30
10855683006965ULTRADRAPE 2Ultrasound Guided Peripheral Intravenous Barrier a34-102025-05-20
20855683006962ULTRADRAPE 2Ultrasound Guided Peripheral Intravenous Barrier a34-102025-05-20
10303410000033AquaflexULTRASOUND GEL PAD 04-95-8203112024-11-20
10303410000026AquaflexULTRASOUND GEL PAD 04-90-8203112024-08-28
10855683006866Eclipse Probe Cover38-01-12021-12-31
00855683006739Timm Medical57-05-1447382019-11-11
10855683006347ECLIPSEPROBE COVER-LATEX FREE38-012016-12-19
10855683006354ECLIPSEPROBE COVER-LATEX FREE38-032016-12-19
10855683006361AQUAGELLUBRICATING GEL57-052016-12-19
00855683006371AQUAGELLUBRICATING GEL57-202016-12-19
10855683006545Ultradrape34-152023-09-18
10855683006910BrainScope99-1000-0042023-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08887500730017SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
00627987071429NixitMAYER LABORATORIES, INC.KMJ2025-09-16
06936603230992Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
30080196074192MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
40080196074199MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
17290100666156Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2025-04-02
00858276007557Sterile Bacteriostatic Lubricating GelMicro-tech UsaKMJ2025-03-05
00850025860482Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
10850025860489Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860062Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860215Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860277Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007434Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007465Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007496Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850025860079Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860222Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860284Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007441Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007472Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007502Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850041319001EsoCoolNuvaira, Inc.KMJ2025-01-29
00850041319018EsoCoolNuvaira, Inc.KMJ2025-01-29
00850058254623EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254630EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254647EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254654EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16