FDA.reportPublic FDA data

LHB Industries

Primary DI
00009235421871
Brand
LHB Industries
Company
The Lighthouse For The Blind
Model
Ultra Flex XL w/wipe
Catalog number
2204045
Device description
Male External Catheter, X-Large 41mm, Non Latex w/Skin wipe
Published
2021-10-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KOASurgical Instruments, G-U, Manual (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00009235421871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00009235421871000092354218710092354218710009235421871

GMDN Terms#

Term, Definition table
TermDefinition
Urinary incontinence penis sheath/port, single-use, non-sterileA non-sterile 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051731214
Device count
1
Premarket exempt
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
00009235421796LHB IndustriesUltraFlex Small w/ wipe22040372021-10-01
00009235421802LHB IndustriesUltra Flex Small22040382021-10-01
00009235421819LHB IndustriesUltra Flex Medium w/ wipes22040392021-10-01
00009235421826LHB IndustriesUltra Flex Medium22040402021-10-01
00009235421833LHB IndustriesUltra Flex Intermed w/ wipe220400412021-10-01
00009235421840LHB IndustriesUltra Flex Intermed22040422021-10-01
00009235421857LHB IndustriesUltra Flex Large w/wipe22040432021-10-01
00009235421864LHB IndustriesUltra Flex Large22040442021-10-01
00009235421888LHB IndustriesUltra Flex XL22040462021-10-01
00009235421895LHB IndustriesWide Band Small22040502021-10-01
00009235421901LHB IndustriesWide Band Medium220400512021-10-01
00009235421918LHB IndustriesWide Band Intermed22040522021-10-01
00009235421925LHB IndustriesWide Band Large 22040532021-10-01
00009235421932LHB IndustriesWide Band Large w/ wipe2204053-W2021-10-01
00009235000007Oxyband128040002021-10-05
00009235421772Oxyband12021-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850081334040Zenflow Spring® Implant Retrieval DeviceZENFLOW, INC.KOA2026-05-22
00198506090882ELMED INCORPORATEDELMED INCORPORATEDKOA2026-05-15
00190776419288MillenniumAvalign Technologies, Inc.KOA2026-04-14
14026704941619PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
24026704941616PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
00198506089640ELMED INCORPORATEDELMED INCORPORATEDKOA2026-03-17
10198956293243CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00198506088537ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
00198506088599ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
50198956293241CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00190776417307MillenniumAvalign Technologies, Inc.KOA2026-02-20
00198506088155ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-22
00198506087363ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00198506087424ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00190776414351MillenniumAvalign Technologies, Inc.KOA2025-10-23
00198506086151ELMED INCORPORATEDELMED INCORPORATEDKOA2025-10-20
00190776413569MillenniumAvalign Technologies, Inc.KOA2025-10-10
00190776412982MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412999MillenniumAvalign Technologies, Inc.KOA2025-10-07
00190776412722MillenniumAvalign Technologies, Inc.KOA2025-10-06
00842180149724ELMED INCORPORATEDELMED INCORPORATEDKOA2025-09-30
00190776410360MillenniumAvalign Technologies, Inc.KOA2025-09-11
00190776409562MillenniumAvalign Technologies, Inc.KOA2025-09-03
05996617000050UroDapter®/MID-IIPHARMICO MEDICAL Korlátolt Felelősségű TársaságKOA2025-08-25
00190776408459MillenniumAvalign Technologies, Inc.KOA2025-08-11
00190776408121MillenniumAvalign Technologies, Inc.KOA2025-08-06
00198506084416ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084430ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084447ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05
00198506084454ELMED INCORPORATEDELMED INCORPORATEDKOA2025-08-05