FDA.reportPublic FDA data

Men's Liberty Acute

Primary DI
10653599001957
Brand
Men's Liberty Acute
Company
BIODERM, INC.
Model
2102616
Device description
Men's Liberty Acute Compatible with Suction with CathGrip
Published
2023-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NOADevice, Paste-On For Incontinence, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NOADevice, Paste-On For Incontinence, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653599001957PackageGS135In Commercial Distribution
00653599001950PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065359900195710653599001957
00653599001950006535990019506535990019500653599001950

GMDN Terms#

Term, Definition table
TermDefinition
Urinary incontinence penis sheath/port, single-useA device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-864-6755CustomerCare@BioDermInc.com

Regulatory Flags#

DUNS number
114773653
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653599001971CathGrip51023NWCA2024-03-20
10653599002015CathGrip51301NACA2024-03-20
10653599002022CathGrip51301LPNACA2024-03-20
10653599002121CathGrip51350NSNACA2024-03-20
10653599002138CathGrip53002NSNACA2024-03-20
10653599002145CathGrip54002NSNACA2024-03-20
10653599002152CathGrip54003NSNACA2024-03-20
10653599001995CathGrip51300NACA2024-03-08
10653599002008CathGrip51300LPNACA2024-03-08
10653599001872CathGrip51023NSNWLA2024-02-07
10653599001896CathGrip51250LPNSNALA2024-02-07
10653599001902CathGrip51300LPNSNALA2024-02-07
10653599001940Men's Liberty Acute21026152024-02-07
10653599001988CathGrip51250NACA2024-02-07
10653599002039CathGrip51350NACA2024-02-07
10653599002053CathGrip51023NSNWCA2024-02-07
10653599002060CathGrip51250NSNACA2024-02-07
10653599002077CathGrip51250LPNSNACA2024-02-07
10653599002084CathGrip51300NSNACA2024-02-07
10653599002091CathGrip51300LPNSNACA2024-02-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653599002476Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2026-01-23
00653599002452Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2026-01-23
00653599002483Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2026-01-23
00653599002254Men's LibertyARGENTUM MEDICAL, LLCNOA2024-06-07
10653599002251Men's LibertyARGENTUM MEDICAL, LLCNOA2024-06-07
00653599001943Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2024-02-07
00653599002162Men's LibertyARGENTUM MEDICAL, LLCNOA2024-02-07
10653599001940Men's Liberty AcuteBIODERM, INC.NOA2024-02-07
10653599002169Men's LibertyBIODERM, INC.NOA2024-02-07
00653599002186Men's LibertyARGENTUM MEDICAL, LLCNOA2024-02-07
00653599001950Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2023-10-05
10687225793749PEDIATRIC URINE COLLECTORS, CLEANPRECISION DYNAMICS CORPORATIONNOA2023-06-20
00610075055975HollisterHOLLISTER INCORPORATEDNOA2022-12-01
00610075055982HollisterHOLLISTER INCORPORATEDNOA2022-12-01
00610075098736HollisterHOLLISTER INCORPORATEDNOA2022-12-01
10610075055972HollisterHOLLISTER INCORPORATEDNOA2022-12-01
10610075055989HollisterHOLLISTER INCORPORATEDNOA2022-12-01
20610075098730HollisterHOLLISTER INCORPORATEDNOA2022-12-01
00653599001837Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2022-06-23
10653599001834Men's Liberty AcuteBIODERM, INC.NOA2022-06-23
00653599001813Men's LibertyARGENTUM MEDICAL, LLCNOA2022-05-04
10653599001810Men's LibertyBIODERM, INC.NOA2022-05-04
00653599001790Men's LibertyARGENTUM MEDICAL, LLCNOA2021-12-20
00653599001806BioDerm (Men's Liberty Acute) 4-PackARGENTUM MEDICAL, LLCNOA2021-12-20
10653599001797Men's LibertyBIODERM, INC.NOA2021-12-20
10653599001803BioDerm (Men's Liberty Acute) 4-PackBIODERM, INC.NOA2021-12-20
00653599001639Men's Liberty AcuteARGENTUM MEDICAL, LLCNOA2021-09-20
10653599001636Men's Liberty AcuteBIODERM, INC.NOA2021-09-20
00653599001646Men's LibertyARGENTUM MEDICAL, LLCNOA2021-09-20
00653599001653Faceplate StripARGENTUM MEDICAL, LLCNOA2021-09-20