FDA.reportPublic FDA data

Up&Up

Primary DI
10894025001732
Brand
Up&Up
Company
TARGET CORPORATION
Model
245-03-0534
Device description
TARGET LUBE JELLY 4 OZ - (TGT-024-4OZ)
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
10894025001732PackageGS112Not in Commercial Distribution
00894025001735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1089402500173210894025001732
00894025001735008940250017358940250017350894025001735

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 Volume4Fluid Ounce

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
952-351-4218GayleD@currysales.com

Regulatory Flags#

DUNS number
006961700
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
00829576076703Up & UpEarly Ovulation Test2020-01-14
00850056441261Target Up&Up8500564412612026-06-25
00850056441254Target Up&Up8500564412542026-06-25
00850056441209Target Up&UpGLOVE-ARMBRUST-3.9MIL-BLUE-BOX-1X50-M2024-12-27
00850056441247Target Up&UpGLOVE-ARMBRUST-3.2MIL-BLUE-BOX-1X50-M2026-02-05
00017276229370Up&Up2450706862020-01-24
00095072096006Up&Up 245-09-78819SMPP1002TG2026-04-22
00017276226171Up&Up2450701462020-02-28
00017276226188Up&Up2450702042020-02-28
00017276226218Up&Up2450704082020-02-28
00017276226270Up&Up2450710342020-02-28
00017276229363Up&Up2450706792020-01-24
00017276231625Up&Up2450706522020-03-30
00017276233094Up&Up2450705762020-02-28
00017276238655Up&Up2450778132022-02-14
00017276239614up&up2450749432024-02-05
00751774733532Up & Up Advanced Early Result Pregnancy Test2020-09-21
00751774733631Up & Up Advanced Early Result Pregnancy Test2020-09-28
06941937216819Up & Up245-07-02932022-07-12
00310119304242up & up multipurpose solution630424FCP-41222026-01-09

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