Up & Up

GUDID 10492450308633

A convenience kit consisting of 7 up&up One Step Ovulation Predictor Tests + 1 up&up Early Result Pregnancy Test

TARGET CORPORATION

Total human chorionic gonadotropin (HCG) IVD, kit, immunochromatographic test (ICT), rapid

• Primary Device ID: 10492450308633
• NIH Device Record Key: 52c8b7ff-53b6-4cc5-91ec-3f90c3d97276
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Up & Up
• Version Model Number: One Step Ovulation Predictor PLUS Early Result Pre
• Company DUNS: 006961700
• Company Name: TARGET CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx
• Phone: 1-800-910-6874
• Email: xx@xx.xx

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00492450308636 [Primary]
GS1	10492450308633 [Package]; Contains: 00492450308636; Package: Shipping case [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002867

FDA Product Code

• LCX: Kit, Test, Pregnancy, Hcg, Over The Counter

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-15
• Device Publish Date: 2018-02-12

On-Brand Devices [Up & Up ]

• 10492450308633: A convenience kit consisting of 7 up&up One Step Ovulation Predictor Tests + 1 up&up Early Resul
• 10492450308626: up&up 10ct Digital Ovulation Test
• 10492450308619: up&up 3ct Early Result Pregnancy Test
• 00492450308605: up&up 2ct Early Result Pregnancy Test
• 00492450303419: CB8 Digital Pregnancy Stick Target DPS Digital Early (ER)
• 00492450302887: FPPL Target DPS +/- (ER)
• 20642632760408: PC40-TG
• 10767056131320: Ear + Forehead digital thermometer
• 10756063059253: Up & Up Kids Silicone Ear Plugs 6 pair + Case
• 10756063059246: Up & Up Silicone Ear Plugs 8 pair with Case
• 10756063059239: Up & Up Soft Foam Ear Plugs 12 pair
• 10756063059222: Up & Up Women's Foam Ear Plugs 12 pair
• 10756063059215: Up & Up Soft Foam Ear Plugs 50 pair
• 00751774077704: PLPL Target TPS Early Result
• 10855606007086: A convenience kit consisting of 7 One-step Ovulation Tests and 1 One-step Pregnancy Test
• 10855606007062: Digital Pregnancy Test
• 10855606007048: Early-Result Pregnancy Test
• 10855606007024: Early-Result Pregnancy Test
• 00845717009355: Up&Up Basal Digital Thermometer
• 00845717009324: Up&Up Automatic Digital BP Monitor, Wide-Range Cuff
• 00845717009317: Up&Up Blood Pressure Monitor with Adult Wrist Cuff
• 00845717009300: Up&Up 10-Second Flexible Tip Digital Thermometer
• 00845717009294: Up&Up 30-Second Rigid Tip Digital Thermometer
• 00845717009270: Up&Up Probe Covers, 40 count
• 00845717009362: Up&Up Heat Wrap - Back/Large Areas, 3 count
• 00490300513087: Disposable Nursing Pads
• 00490300512721: 03 05 1272
• 10829576076700: A convenience kit consisting of 10 Ovulation Test devices and 1 One Step Pregnancy Test.
• 10834533001176: 245040457
• 10834533000834: 245040211
• 10834533000827: 245040206
• 10834533000803: 245040191
• 10834533000797: 245040188
• 10834533000735: 245040845
• 10834533000728: 245040537
• 10834533000711: 245040522
• 10834533000681: 245040135
• 10834533000551: 245040060
• 10834533000544: 245040306
• 10834533000537: 245040305
• 10834533000520: 245040059
• 00078041200352: Contact Lens Case 4 Ct.
• 00078041200345: Contact Lens Case 12 Ct.
• 00078041200338: Contact Lens Case - 1Ct.
• 00756063059294: Contact Lens Case 12ct
• 00756063059287: Contact Lens Case 4ct
• 00756063059263: Contact Lens Case 1ct
• 00829576022205: Sleeping Earplugs 12 Pair
• 00829576021956: Kids' Silicone Putty Earplugs 6 Pairs
• 00829576021949: Ultra Soft Silicone Putty Earplugs 8 Pair