GOODSENSE

GUDID 00846036009446

One Step Pregnancy Test, 1 count

GEISS, DESTIN & DUNN, INC

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

• Primary Device ID: 00846036009446
• NIH Device Record Key: 59a5fea8-8e48-437d-8f1c-9ab448be9982
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GOODSENSE
• Version Model Number: G600944
• Company DUNS: 076059836
• Company Name: GEISS, DESTIN & DUNN, INC
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846036009446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150022

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-11
• Device Publish Date: 2022-05-03

On-Brand Devices [GOODSENSE]

• 20846036002724: Sterile Saline Wound Wash. Packaged in an Aerosol (BOV) can.
• 00846036001594: Digital Thermometer
• 00846036001570: Flex Tip Digital Thermometer
• 10846036004998: Adhesive Pads, all one size, 3 IN x 4 IN (76 mm x 101 mm)
• 10846036004219: Tan Large Nasal Strips
• 10846036004196: Clear Medium Nasal Strips
• 10846036003373: Antibacterial Sheer Adhesive Bandages, assorted sizes, 1 IN x 3 IN (25 mm x 76 mm); Fingerband 3
• 10846036001430: Flexible Fabric Adhesive Bandages, all one size, 2 IN x 4 IN (50 mm x 101 mm)
• 10180410000894: Sterile Pads, all one size, 2 IN x 2 IN (50 mm x 50 mm)
• 10180410000887: Sterile Pads, all one size, 3 IN x 3 IN (76 mm x 76 mm)
• 10180410000870: Water Shield Plus Adhesive Bandages, assorted sizes, 1 N x 1 1/2 IN (25 mm x 63 mm); 3/4 IN x 2
• 10180410000245: Strong Strips Adhesive Bandages, all one size, 1 IN x 3 1/4 IN (25 mm x 82 mm)
• 10180410000238: Tender Tape, 2 IN x 5 YDS (50 mm x 4.5 m) stretched; 2 IN x 2.2 YDS (50 mm x 2 m)
• 00846036009446: One Step Pregnancy Test, 1 count