FDA.reportPublic FDA data

LSL HEALTHCARE

Primary DI
00661392055650
Brand
LSL HEALTHCARE
Company
LSL Industries, LLC
Model
1628
Catalog number
1628
Device description
Specimen Collection w/ hCG Test Kit, Vacutainer & Tube
Published
2025-06-06
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
FMHCONTAINER, SPECIMEN, STERILE
JHIVisual, pregnancy hCG, prescription use
JTWSYSTEM, TRANSPORT, AEROBIC
LZAPolymer patient examination glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMHContainer, Specimen, SterilePathology1
JHIVisual, Pregnancy Hcg, Prescription UseClinical Chemistry2
JTWSystem, Transport, AerobicMicrobiology1
LZAPolymer Patient Examination GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10661392055657PackageGS150In Commercial Distribution
00661392055650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066139205565710661392055657
00661392055650006613920556506613920556500661392055650

GMDN Terms#

Term, Definition table
TermDefinition
Non-evacuated urine specimen container IVD, no additiveA covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a urine specimen for culture, analysis, and/or other investigation. This is a single-use device.

Regulatory Flags#

DUNS number
046703096
Device count
1
DM exempt
true
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
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
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
20197344225894MEDLINEMEDLINE INDUSTRIES, INC.FMH2026-10-16
D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100PNK1MYNTMynt ProfessionalLZA2026-10-16
00199972000641CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZA2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZA2026-10-15