FDA.reportPublic FDA data

Nuprep Skin Prep Gel

Primary DI
00891893002246
Brand
Nuprep Skin Prep Gel
Company
D. O. WEAVER AND COMPANY
Model
10-25; 10-25S; 10-61
Catalog number
10-25; 10-25S; 10-61; 10-65
Device description
Single 25g tube of Nuprep Skin Prep Gel (unit of use).
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRXElectrode, Electrocardiograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRXElectrode, ElectrocardiographCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K885306000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K885306000NUPREPWeaver & Co.1989-02-23DRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10891893002243PackageGS16In Commercial Distribution
20891893002240PackageGS11In Commercial Distribution
30891893002247PackageGS11In Commercial Distribution
40891893002244PackageGS120In Commercial Distribution
00891893002246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089189300224310891893002243
2089189300224020891893002240
3089189300224730891893002247
4089189300224440891893002244
00891893002246008918930022468918930022460891893002246

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
8005252130customerservice@weaverandcompany.com

Regulatory Flags#

DUNS number
039143201
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00891893002253Ten20 Conductive Paste10-20-4T; 10-20-4TK2016-09-01
00891893002284Nuprep Skin Prep Gel10-91; 10-91K2023-11-17
10891893002281Nuprep Skin Prep Gel10-91; 10-91K2023-11-17
30891893002278Ten20 Conductive Paste10-20-1S10-20-1S2021-10-06
00891893002222Ten20 Conductive Paste10-20-42016-09-01
00891893002239Ten20 Conductive Paste10-20-82016-09-01
00891893002260Ten20 Conductive Paste10-20-2S; 10-20-22016-09-01
10891893002274Ten20 Conductive Paste10-20-110-20-12018-05-15
00891893002277Ten20 Conductive Paste10-20-1S10-20-1S2021-10-06
30891893002247Nuprep Skin Prep Gel10-25; 10-25S; 10-6110-25; 10-25S; 10-61; 10-652016-09-01
00891893002215Nuprep Skin Prep Gel10-30; 10-30K2016-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060038511034Ambu® WhiteSensor 40554Ambu A/SDRX2026-08-07
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00851491007562AccuSensorLynn Medical Instrument Co.DRX2026-07-24
G828HARNESS0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253016663KendallCardinal Health 200, LLCDRX2024-02-28
20192253016670KendallCardinal Health 200, LLCDRX2024-02-28
20192253017424KendallCardinal Health 200, LLCDRX2024-02-28
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
10841522130298Eclipse ProSPACELABS HEALTHCARE (WASHINGTON), INCDRX2023-02-23
08033003267424NAFIAB SPADRX2021-03-31
20192253016755KendallCardinal Health 200, LLCDRX2021-02-23
20192253017196KendallCardinal Health 200, LLCDRX2020-11-17
08906035281044Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281174Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035281501Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
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08906035282911Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282942Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20
08906035282959Ambu WhiteSensorMEDICO ELECTRODES INTERNATIONAL LIMITEDDRX2020-08-20