Kimono Swirl 3836

GUDID 10016169038362

Latex Condom 36-ct

MAYER LABORATORIES, INC.

Basic male condom, Hevea-latex
Primary Device ID10016169038362
NIH Device Record Key8235c20a-1cf8-4a53-9a1a-43e93e604f5a
Commercial Distribution StatusIn Commercial Distribution
Brand NameKimono Swirl
Version Model NumberSwirl Latex Condoms
Catalog Number3836
Company DUNS175425982
Company NameMAYER LABORATORIES, INC.
Device Count36
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com
Phone+1(510)229-5300
Emaildavidm@mayerlabs.com

Device Dimensions

Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter
Width54 Millimeter
Length160 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *NO DIRECT SUNLIGHT OR HEAT
Storage Environment TemperatureBetween 40 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100016169038365 [Primary]
GS110016169038362 [Package]
Contains: 20016169038369
Package: MASTER CARTON [8 Units]
In Commercial Distribution
GS120016169038369 [Package]
Contains: 00016169038365
Package: FOLDED CARTON [6 Units]
In Commercial Distribution
GS130016169038366 [Unit of Use]

FDA Product Code

HISCONDOM

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-03

On-Brand Devices [Kimono Swirl]

20016169541050Personal Lubricant - Silicone 2 ml
10016169541046Personal Lubricant - Silicone 100 ml
10016169540056Natural Personal Lubricant 3 ml
20016169540046Natural Personal Lubricant - 100 ml
10016169038362Latex Condom 36-ct
20016169038123Latex Condom 12-ct

Trademark Results [Kimono Swirl]

Mark Image

Registration | Serial
Company
Trademark
Application Date
KIMONO SWIRL
KIMONO SWIRL
97296474 not registered Live/Pending
Mayer Laboratories, Inc.
2022-03-04

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