Smart Sense Tampons

GUDID 10883967382245

KMART HOLDING CORPORATION

Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented Menstrual tampon, scented

• Primary Device ID: 10883967382245
• NIH Device Record Key: 9b2b7522-a17c-4064-b8c3-62a9b8099e98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Smart Sense Tampons
• Version Model Number: BKMSGR18
• Company DUNS: 131978533
• Company Name: KMART HOLDING CORPORATION
• Device Count: 18
• 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	00883967382248 [Primary]
GS1	07290016625158 [Unit of Use]
GS1	10883967382245 [Package]; Contains: 00883967382248; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042773

FDA Product Code

• HIL: Tampon, Menstrual, Scented, Deodorized

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: 2016-09-20

On-Brand Devices [Smart Sense Tampons]

• 10883967418388: Multipack Box of 36 Tampons - 18 Regular absorbency and 18 Super Absorbency
• 10883967418364: BKMSGP36
• 10883967418357: BKMUR18
• 10883967418340: BKMGR36
• 10883967382269: BKMGS18
• 10883967382252: BKMSGS18
• 10883967382245: BKMSGR18
• 10883967382238: BKMGR18