Men's Liberty Acute

GUDID 10653599000844

Men's Liberty Acute with CathGrip

BIODERM, INC.

Urinary incontinence penis sheath/port, single-use, non-sterile
Primary Device ID10653599000844
NIH Device Record Key9ebc2258-690a-4866-aeeb-768d34a9298b
Commercial Distribution StatusIn Commercial Distribution
Brand NameMen's Liberty Acute
Version Model NumberBIO2102610
Company DUNS114773653
Company NameBIODERM, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com
Phone800-864-6755
EmailCustomerCare@BioDermInc.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100653599000847 [Primary]
GS110653599000844 [Package]
Contains: 00653599000847
Package: box [35 Units]
In Commercial Distribution
HIBCCM45621026100 [Secondary]

FDA Product Code

NOADevice, Paste-On For Incontinence, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-10
Device Publish Date2020-01-02