Exchange Select Tampons

GUDID 10614299396378

Aafes

Menstrual tampon, unscented

• Primary Device ID: 10614299396378
• NIH Device Record Key: 6d2fc5c7-fa4d-41da-b283-123c84956ce3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exchange Select Tampons
• Version Model Number: BAFAS20
• Company DUNS: 001695568
• Company Name: Aafes
• Device Count: 20
• 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00614299396371 [Primary]
GS1	07290016625028 [Unit of Use]
GS1	10614299396378 [Package]; Contains: 00614299396371; Package: CASE [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001641

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: 2016-09-20

On-Brand Devices [Exchange Select Tampons]

• 10614299407203: BAFUS18
• 10614299407166: BAFUR18
• 10614299402062: BAFGS18
• 10614299402055: BAFGR20
• 10614299396408: Multi pack of 40 tampons - 8 Light, 16 Regular and 16 Super absorbency
• 10614299396385: BAFAR20
• 10614299396378: BAFAS20