FDA.reportPublic FDA data

LSL HEALTHCARE

Primary DI
10661392002323
Brand
LSL HEALTHCARE
Company
LSL Industries, LLC
Model
1555
Catalog number
1555
Device description
Urine Specimen Collection Kit
Published
2025-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OIBBlood and urine collection kit (excludes HIV testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIBBlood And Urine Collection Kit (Excludes Hiv Testing)Pathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10661392002323PackageGS1100In Commercial Distribution
00661392002326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066139200232310661392002323
00661392002326006613920023266613920023260661392002326

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, medicatedA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
046703096
Device count
1
DM exempt
true
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
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
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10192253066760Aero-MedAERO-MED, LLCOIB2026-09-28
10192253067644Aero-MedAERO-MED, LLCOIB2026-09-28
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10885380190261Aero-MedAERO-MED, LLCOIB2026-09-28
10885380190988Aero-MedAERO-MED, LLCOIB2026-09-28
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10885380206580Aero-MedAERO-MED, LLCOIB2026-09-28
10885380206597Aero-MedAERO-MED, LLCOIB2026-09-28
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10885380208836Aero-MedAERO-MED, LLCOIB2026-09-28
10885380213939Aero-MedAERO-MED, LLCOIB2026-09-28
10885380213908Aero-MedAERO-MED, LLCOIB2026-09-25
10885380213922Aero-MedAERO-MED, LLCOIB2026-09-25