FDA.reportPublic FDA data

Walgreens

Primary DI
10311917206551
Brand
Walgreens
Company
WALGREEN CO.
Model
7W926
Device description
4oz (113g) Lubricating Jelly - Personal Lubricant
Published
2020-01-29
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

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
K012203000
K180923000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012203000CLAY-PARK LABS, INC. - LUBRICATING JELLYClay-Park Labs, Inc.2001-08-27NUC
K180923000Personal Lubricating JellyPerrigo New York, Inc.2018-07-09NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10311917206551PackageGS172In Commercial Distribution
00311917206554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1031191720655110311917206551
00311917206554003119172065543119172065540311917206554

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
Weight113Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-719-9260consumerrelations.pq@walgreens.com

Regulatory Flags#

DUNS number
008965063
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
00311917156064WALGREENS2576322020-07-22
00311917080062Walgreens7610162026-08-26
00311917086569Walgreens1666772026-08-21
00311917086590Walgreens1666372026-08-21
00311917122045Walgreens5052882023-03-09
00311917158952Walgreens276743WRX2767432020-07-14
00311917014876Walgreens6772599288502016-12-20
00311917048130Walgreens6548789288562016-12-20
00311917014920Walgreens6772579288522016-12-20
00311917025360Walgreens6545679288572016-12-20
00311917048154Walgreens6548829288582016-12-20
00311917085685Walgreens7208802026-05-08
00311917085692Walgreens7208932026-05-08
00311917085739Walgreens7208942026-05-08
00311917085753Walgreens7208922026-05-08
00311917085760Walgreens7208972026-05-08
00311917077598Walgreens7377342026-04-28
00311917151434Walgreens2205442019-11-29
00311917151472Walgreens2205502019-11-28
00311917219288Walgreens2729422020-11-26

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08721325867261SVibeAMOREO EUROPE SOCIEDAD LIMITADA.NUC2026-08-25
00651277001681Cock Oil - Silicone 9ozCockOil LLCNUC2026-08-21
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