FDA.report

LHB Industries

Primary DI
00009235421925
Brand
LHB Industries
Company
The Lighthouse For The Blind
Model
Wide Band Large
Catalog number
2204053
Device description
Male External Catheter, Wide Band, Large 36mm
Published
2021-10-01
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

Related Records

Product Codes

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

Product Code Classifications

CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00009235421925PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00009235421925000092354219250092354219250009235421925

GMDN Terms

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

Regulatory Flags

DUNS number
051731214
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
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 DIBrandModelCatalogPublished
00009235000007Oxyband128040002021-10-05
00009235421772Oxyband12021-10-05
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
00009235421871LHB IndustriesUltra Flex XL w/wipe22040452021-10-01
00009235421888LHB IndustriesUltra Flex XL22040462021-10-01
00009235421895LHB IndustriesWide Band Small22040502021-10-01
00009235421901LHB IndustriesWide Band Medium220400512021-10-01
00009235421918LHB IndustriesWide Band Intermed22040522021-10-01
00009235421932LHB IndustriesWide Band Large w/ wipe2204053-W2021-10-01

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00842180149168ELMED INCORPORATEDELMED INCORPORATEDKOA2025-07-29
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