FDA.reportPublic FDA data

Nuprep Skin Prep Gel

Primary DI
00891893002284
Brand
Nuprep Skin Prep Gel
Company
D. O. WEAVER AND COMPANY
Model
10-91; 10-91K
Device description
Single-use cup of Nuprep Skin Prep Gel (unit of use)
Published
2023-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10891893002281PackageGS124In Commercial Distribution
20891893002288PackageGS124In Commercial Distribution
30891893002285PackageGS13In Commercial Distribution
00891893002284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089189300228110891893002281
2089189300228820891893002288
3089189300228530891893002285
00891893002284008918930022848918930022840891893002284

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
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
00891893002246Nuprep Skin Prep Gel10-25; 10-25S; 10-6110-25; 10-25S; 10-61; 10-652016-09-01
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
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G828PACKAGE0PhysiotraceNimbleHeart, Inc.DRX2026-05-28
08809083949129TELECTRODEBIOPROTECH INC.DRX2026-04-30
08809083949136TELECTRODEBIOPROTECH INC.DRX2026-04-30
20192253017080KendallCardinal Health 200, LLCDRX2023-03-16
08033003267424NAFIAB SPADRX2021-03-31
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