GOODSENSE

GUDID 00846036009446

One Step Pregnancy Test, 1 count

GEISS, DESTIN & DUNN, INC

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

• 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