FDA.reportPublic FDA data

EQUATE

Primary DI
50681131034802
Brand
EQUATE
Company
WAL-MART STORES, INC.
Model
550337118
Device description
EQUATE LUB JELLY W/PUMP 8 OZ - (WM-024-8OZ)
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
K070623000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070623000PHARMAPAC LUBRICATING JELLYPharmapac, LLC2007-08-31NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50681131034802PackageGS124In Commercial Distribution
00681131034807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5068113103480250681131034802
00681131034807006811310348076811310348070681131034807

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume8Fluid Ounce

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
479-204-8686Tiffany.Burnett@walmart.com

Regulatory Flags#

DUNS number
051957769
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
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069740214114323H Medical69740214114322026-07-31
069740214114943H Medical69740214114942026-07-31
06974021419490EQUATEFRT-022026-07-31
06979191882112Nanacare69791918821122026-07-31
06979191882228Nanacare69791918822282026-07-31
06979191882242Nanacarewhite2026-07-31
06979191882273BadBuddy69791918822732026-07-31
06979191882280Nanacare69791918822802026-07-31
06979191883690EQUATEwhite2026-07-31
06979191883706EQUATEblue2026-07-31
06979191883713EQUATEwhite2026-07-31
06979191883720EquateWhite2026-07-31
00194346614035equateBPHJT3-JWM2026-07-28
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00194346693122EquateWAL4545V4WAL4545V42026-06-02
00194346693139EquateWAL4245V4WAL4245V42026-06-02

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