FDA.reportPublic FDA data

Men's Liberty Acute

Primary DI
00653599002452
Brand
Men's Liberty Acute
Company
ARGENTUM MEDICAL, LLC
Model
MLAM
Device description
Men's Liberty Acute Mobility
Published
2026-01-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00653599002469PackageGS135In Commercial Distribution
00653599002452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00653599002469006535990024696535990024690653599002469
00653599002452006535990024526535990024520653599002452

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
888-551-0188customercare@bravidamedical.com

Regulatory Flags#

DUNS number
091449079
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00653599000250CathGrip511002020-01-07
00653599000274CathGrip51250BOM51250BX2020-01-07
00653599000298CathGrip51250NSBOM51250NSBX2020-01-08
00653599000311CathGrip51250NSNA2020-01-08
00653599000328CathGrip51250NSNW2020-01-16
00653599000342CathGrip51250SFPNA2021-05-12
00653599000366CathGrip51300BOM51300BX2020-01-07
00653599000373CathGrip51300NSBOM51300NSBX2020-01-08
00653599000380CathGrip51300NSNA2020-01-09
00653599000397CathGrip51300SFP2020-01-16
00653599000403CathGrip51300SFPNA2020-01-16
00653599000410CathGrip51301BOM51301BX2020-01-07
00653599000434CathGrip51301NSBOM51301NSBX2020-01-08
00653599000458CathGrip51301NSNA2020-01-16
00653599000489CathGrip51301SFP2020-01-16
00653599000496CathGrip51301SFPNA2020-07-07
00653599000519CathGrip513032020-01-07
00653599000526CathGrip51350BOM51350BX2020-01-07
00653599000533CathGrip51350NSBOM51350NSBX2020-01-08
00653599000540CathGrip51350NSNA2023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00653599002476Men'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
10653599001957Men's Liberty AcuteBIODERM, INC.NOA2023-10-05
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