SMART SENSE Tampon

GUDID 10883967418371

KMART HOLDING CORPORATION

Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented Menstrual tampon, unscented

• Primary Device ID: 10883967418371
• NIH Device Record Key: f1a40f56-ed6f-4b29-a0c0-f028165d45c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMART SENSE Tampon
• Version Model Number: BKMPS50
• Company DUNS: 131978533
• Company Name: KMART HOLDING CORPORATION
• Device Count: 50
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883967418374 [Primary]
GS1	07290016625059 [Unit of Use]
GS1	10883967418371 [Package]; Contains: 00883967418374; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020535

FDA Product Code

• HEB: Tampon, Menstrual, Unscented

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-09
• Device Publish Date: 2017-05-02

Devices Manufactured by KMART HOLDING CORPORATION

• 10883967382238 - Smart Sense Tampons: 2019-12-09
• 10883967382245 - Smart Sense Tampons: 2019-12-09
• 10883967382252 - Smart Sense Tampons: 2019-12-09
• 10883967382269 - Smart Sense Tampons: 2019-12-09
• 10883967418340 - SMART SENSE Tampons: 2019-12-09
• 10883967418364 - SMART SENSE Tampons: 2019-12-09
• 10883967418371 - SMART SENSE Tampon: 2019-12-09
• 10883967418371 - SMART SENSE Tampon: 2019-12-09
• 00883967296910 - Image Essentials One Step Pregnancy Test: 2018-07-06 FPPL Kmart Image Essentials SPS +/-