FDA.reportPublic FDA data

LSL HEALTHCARE

Primary DI
00661392025646
Brand
LSL HEALTHCARE
Company
LSL Industries, LLC
Model
1622MS
Catalog number
1622MS
Device description
FOLEY TRAY CLOSED SYSTEM
Published
2025-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FCNUrinary drainage collection kit, for indwelling catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCNUrinary Drainage Collection Kit, For Indwelling CatheterGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00661392025646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00661392025646006613920256466613920256460661392025646

GMDN Terms#

Term, Definition table
TermDefinition
Indwelling urethral catheterization kit, adultA collection of devices that includes an indwelling urethral catheter which incorporates a balloon (commonly known as a Foley catheter), and devices associated with catheter introduction/function (e.g., gloves, lubricating gel, drapes), intended for urinary drainage from the bladder of an adult or paediatric patient. The catheter will be applied by trained staff and may be coated with an antibiotic to help prevent catheter-associated urinary tract infection (CAUTI). This is a single-use device.

Regulatory Flags#

DUNS number
046703096
Device count
1
DM exempt
true
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
00661392000070LSL HEALTHCARE302530252025-10-30
00661392000100LSL HEALTHCARE626162612025-10-30
00661392000124LSL HEALTHCARE711571152025-10-30
00661392000148LSL HEALTHCARE712271222025-10-30
00661392000186LSL HEALTHCARE713671362025-10-30
00661392000223LSL HEALTHCARE758175812025-10-30
00661392000292LSL HEALTHCARE3067N3067N2025-10-30
00661392000506LSL HEALTHCARE7612SA7612SA2025-10-30
00661392000612LSL HEALTHCARE758075802025-10-30
00661392000674LSL HEALTHCARE762076202025-10-30
00661392001039LSL HEALTHCAREAE66-1TSAE66-1TS2025-10-30
00661392001138LSL HEALTHCARE2524A2524A2025-10-30
00661392001176LSL HEALTHCARE844284422025-10-30
00661392001206LSL HEALTHCAREAE83-2WRAE83-2WR2025-10-30
00661392001251LSL HEALTHCAREAE83-4WLAE83-4WL2025-10-30
00661392001794LSL HEALTHCARE712171212025-10-30
00661392001817LSL HEALTHCARE7127-417127-412025-10-30
00661392001855LSL HEALTHCARE715071502025-10-30
00661392001886LSL HEALTHCARE716071602025-10-30
00661392001930LSL HEALTHCARE7471A7471A2025-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850063139403Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139410Neil Medical Group Neil Medical GroupFCN2025-12-08
00850063139427Neil Medical Group Neil Medical GroupFCN2025-12-08
10192253051629DoverCardinal Health 200, LLCFCN2025-11-07
00661392002388LSL HEALTHCARELSL Industries, LLCFCN2025-10-30
10840330701751ProCureTwin Med, LLCFCN2025-05-31
10840330701768ProCureTwin Med, LLCFCN2025-05-31
10840330701775ProCureTwin Med, LLCFCN2025-05-31
10840330701782ProCureTwin Med, LLCFCN2025-05-31
30840330701755ProCureTwin Med, LLCFCN2025-05-31
30840330701762ProCureTwin Med, LLCFCN2025-05-31
30840330701779ProCureTwin Med, LLCFCN2025-05-31
30840330701786ProCureTwin Med, LLCFCN2025-05-31
00850058254791TruCathHR PHARMACEUTICALS INC.FCN2025-01-16
10192253027686DoverCardinal Health 200, LLCFCN2024-10-14
50192253027684DoverCardinal Health 200, LLCFCN2024-10-14
10192253065480DoverCardinal Health 200, LLCFCN2024-09-03
10192253065497DoverCardinal Health 200, LLCFCN2024-09-03
10192253065619DoverCardinal Health 200, LLCFCN2024-09-03
10192253065626DoverCardinal Health 200, LLCFCN2024-09-03
50192253065488DoverCardinal Health 200, LLCFCN2024-09-03
50192253065495DoverCardinal Health 200, LLCFCN2024-09-03
50192253065617DoverCardinal Health 200, LLCFCN2024-09-03
50192253065624DoverCardinal Health 200, LLCFCN2024-09-03
10192253051612DoverCardinal Health 200, LLCFCN2024-08-08
50192253051610DoverCardinal Health 200, LLCFCN2024-08-08
10850053289085SURGYCOSurgyco LLCFCN2023-12-15
10850053289092SURGYCOSurgyco LLCFCN2023-12-15
10850053289108SURGYCOSurgyco LLCFCN2023-12-15
00850053289088SURGYCOSurgyco LLCFCN2023-12-15