FDA.reportPublic FDA data

HEB

Primary DI
20041220706253
Brand
HEB
Company
H. E. BUTT GROCERY COMPANY
Model
7W9261JC3
Device description
Lubricant Jelly 4 oz. (113g)
Published
2024-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
NUCLubricant, Personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180923000Personal Lubricating JellyPerrigo New York, Inc.2018-07-09NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20041220706253PackageGS124In Commercial Distribution
00041220706259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2004122070625320041220706253
00041220706259000412207062590412207062590041220706259

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007924756
Device count
1
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
false
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
00041220048632H-E-B0412200486322020-07-27
00041220865468H-E-B inControlG202016-12-13
00197870203805H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00197870203812H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00633472000690H.E.BSix Days Sooner Pregnancy TestN/A2025-11-28
00041220569311H.E.B Advanced One Step Pregnancy Test2021-06-13
00041220575763H.E.B Advanced One Step Pregnancy Test2021-06-13
00041220575770H.E.B Advanced Early Result Pregnancy Test2021-06-25
00041220575794H.E.B Advanced Early Result Pregnancy Test2021-06-13
00197870203843H.E.BSix Days Sooner Pregnancy TestN/A2025-11-12
00197870203836H.E.BSix Days Sooner Pregnancy TestN/A2025-11-11
00041220723478H.E.B Advanced One Step Pregnancy Test2021-06-13
00197870203829H.E.BSix Days Sooner Pregnancy TestN/A2025-08-15
00633472000683H.E.BSix Days Sooner Pregnancy TestN/A2025-08-15
00041220245970H-E-B156-757-000156-757-0002016-09-12
00041220924837H-E-B156-878-000156-878-0002016-09-12
00041220823222HEB jelly PERSONAL LUBRICANT7W9261JC12021-12-08
00041220524556H.E.B Digital & Early Result Pregnancy Test 2021-06-25
00041220524563H.E.B Digital Pregnancy Test 2021-06-25
00197870071480H.E.BHEB DIG Wide-Tip & VIS PinkN/A2025-03-03

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Primary DI, Brand, Company table
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