Kimono 07003

GUDID 20116169070038

Latex Condom 3-ct

MAYER LABORATORIES, INC.

Basic male condom, Hevea-latex

• Primary Device ID: 20116169070038
• NIH Device Record Key: a1d163e6-7189-4a73-bfc1-2a682e54edf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kimono
• Version Model Number: MicroThin Ribbed + Sensi-Dots
• Catalog Number: 07003
• Company DUNS: 175425982
• Company Name: MAYER LABORATORIES, INC.
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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

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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00016169070037 [Primary]
GS1	10116169070031 [Package]; Package: MASTER CARTON [8 Units]; In Commercial Distribution
GS1	20116169070038 [Package]; Contains: 00016169070037; Package: SHRINK WRAP [6 Units]; In Commercial Distribution
GS1	30116169070035 [Unit of Use]

FDA Product Code

• HIS: CONDOM

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: 2021-12-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Kimono]

• 10016169090247: Latex Condom 24-ct
• 20016169090121: Latex Condom 12-ct
• 10016169090032: Latex Condom 3-ct
• 10016169070126: Latex Condom 12-ct
• 20116169070038: Latex Condom 3-ct
• 00016169050244: Latex Condom 24-ct
• 00016169050121: Latex Condom 12-ct
• 20116169050030: Latex Condom 3-ct
• 20016169110010: Latex Condoms 1000 ct
• 10016169110006: Latex Condoms 1000 ct
• 20016169050149: Latex Condoms 1000 ct