MAXX 2014

GUDID 20016169020142

Latex Condoms 1000 ct

MAYER LABORATORIES, INC.

Basic male condom, Hevea-latex

• Primary Device ID: 20016169020142
• NIH Device Record Key: 4e9af934-2a9a-4da3-b72a-91618251d03f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXX
• Version Model Number: Kimono MAXX
• Catalog Number: 2014
• Company DUNS: 175425982
• Company Name: MAYER LABORATORIES, INC.
• Device Count: 1000
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com
• Phone: +1(510)229-5300
• Email: davidm@mayerlabs.com

Device Dimensions

• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter
• Width: 52 Millimeter
• Length: 160 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
• Storage Environment Temperature: Between 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016169020148 [Primary]
GS1	10016169020145 [Package]; Package: MASTER CARTON [4 Units]; In Commercial Distribution
GS1	20016169020142 [Package]; Contains: 00016169020148; Package: FOLDED CARTON [1000 Units]; In Commercial Distribution
GS1	30016169020149 [Unit of Use]

FDA Product Code

• HIS: CONDOM

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: 2023-11-13
• Device Publish Date: 2023-11-03

Devices Manufactured by MAYER LABORATORIES, INC.

• 10016169510257 - Aqua Lube: 2023-11-14 Personal Lubricant 144 ct
• 10054003788585 - Union: 2023-11-14 Latex Condoms 144 ct
• 10054003788592 - Union: 2023-11-14 Latex Condoms 144 ct
• 20054003788605 - Union: 2023-11-14 Latex Condoms 144 ct
• 20015874002016 - Nixit: 2023-11-13 Natural Personal Lubricant 3 ml
• 20016169020142 - MAXX: 2023-11-13Latex Condoms 1000 ct
• 20016169020142 - MAXX: 2023-11-13 Latex Condoms 1000 ct
• 20016169038123 - Kimono Swirl: 2023-11-13 Latex Condom 12-ct
• 10016169038362 - Kimono Swirl: 2023-11-13 Latex Condom 36-ct