TopCare Tampons

GUDID 00036800251724

Multi pack of 40 - 8 light/16 Regular/16 Super

TOPCO ASSOCIATES, LLC

Menstrual tampon, unscented

• Primary Device ID: 00036800251724
• NIH Device Record Key: 723f99eb-b20e-46d3-8663-e97996615d2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TopCare Tampons
• Version Model Number: BTCAC40
• Company DUNS: 072943876
• Company Name: TOPCO ASSOCIATES, LLC
• 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: true
• 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 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 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 Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00036800251724 [Primary]
GS1	00036800426603 [Package]; Package: CASE [6 Units]; In Commercial Distribution
GS1	10036800426600 [Package]; Package: CASE [6 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: 5
• Public Version Date: 2019-12-09
• Device Publish Date: 2016-09-20

On-Brand Devices [TopCare Tampons]

• 10036800455327: BTCGS05
• 10036800455310: BTCGR05
• 10036800426648: BTCSGS18
• 10036800426617: BTCGR18
• 10036800426624: BTCSGR18
• 10036800426679: BTCPS36
• 10036800426655: Multi pack of 36 - 8 light/20 Regular/8 Super
• 10036800426709: BTCPR36
• 10036800426693: BTCUS18
• 10036800426686: BTCUR18
• 00036800319233: BTCAP40
• 10036800426587: BTCAS40
• 00036800319202: BTCAR40
• 00036800251724: Multi pack of 40 - 8 light/16 Regular/16 Super
• 10036800426631: BTCGS18
• 10036800441436: BTCGR36
• 10036800441429: BTCGS36
• 00036800400016: Multi pack of 80 - 16 light/32 Regular/32 Super
• 07290016626568: Multi pack of 72 - 16 light/40 Regular/16 Super
• 10036800441443: Multi pack of 36 - 18 Regular and 18 Super absorbency
• 10036800441405: Multi pack of 34 - 17 Regular and 17 Super absorbency
• 10036800264974: BTCXS18
• 10036800264967: BTCXR18