FDA.reportPublic FDA data

LSL HEALTHCARE

Primary DI
10661392045337
Brand
LSL HEALTHCARE
Company
LSL Industries, LLC
Model
8435
Catalog number
8435
Device description
Emesis Bag
Published
2025-05-16
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
FNYBASIN, EMESIS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNYBasin, EmesisGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10661392045337PackageGS1500In Commercial Distribution
00661392045330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066139204533710661392045337
00661392045330006613920453306613920453300661392045330

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, single-useA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, 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
10661392055657LSL HEALTHCARE162816282025-06-06
10661392000152LSL HEALTHCARE712771272025-05-16
10661392000169LSL HEALTHCARE712871282025-05-16
10661392000206LSL HEALTHCARE750175012025-05-16
10661392000602LSL HEALTHCARE752875282025-05-16
10661392000718LSL HEALTHCAREADC3005ADC30052025-05-16
10661392000824LSL HEALTHCAREADL1007ADL10072025-05-16
10661392000831LSL HEALTHCARE7301A7301A2025-05-16
10661392000916LSL HEALTHCARE710471042025-05-16
10661392001739LSL HEALTHCARE710071002025-05-16
10661392001760LSL HEALTHCARE710571052025-05-16
10661392001777LSL HEALTHCARE710671062025-05-16
10661392001784LSL HEALTHCARE710971092025-05-16
10661392001821LSL HEALTHCARE7128-05247128-05242025-05-16
10661392001845LSL HEALTHCARE713171312025-05-16
10661392001869LSL HEALTHCARE715171512025-05-16
10661392001890LSL HEALTHCARE719671962025-05-16
10661392001913LSL HEALTHCARE7199C7199C2025-05-16
10661392001920LSL HEALTHCARE746174612025-05-16
10661392001999LSL HEALTHCARE750875082025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840216128286ASP GLOBALAsp Global, LLCFNY2025-11-20
50198956137712CARDINAL HEALTHCardinal Health 200, LLCFNY2025-08-28
00194613019600MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
00194613019914MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
00194613052256MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
00194613116972MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-08-01
06931918189195AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
06931918190085AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-21
06931918129313AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
06931918140820AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
06931918145467AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
26931918146840Beaver Visitec InterGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
06931918157088AllesetGRI Medical & Electronic Technology Co., Ltd.FNY2025-06-20
00840216128279ASP GLOBALAsp Global, LLCFNY2025-06-17
00840216128293ASP GLOBALAsp Global, LLCFNY2025-06-17
00810180842228DispoSafety Biohazard Bags, 39" x 33", 2 MIL, 33 GallonDynarex CorporationFNY2025-06-16
00810180842235DispoSafety Biohazard Bags, 40" x 46", 2 MIL, 45 GallonDynarex CorporationFNY2025-06-16
00810180842242DispoSafety Biohazard Bags, 40" x 46", 3 MIL, 45 GallonDynarex CorporationFNY2025-06-16
00810180842259DispoSafety Biohazard Bags, 36" x 58", 2 MIL, 45 GallonDynarex CorporationFNY2025-06-16
10661392008080LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
10661392025490LSL HEALTHCARELSL Industries, LLCFNY2025-05-16
10661392027661LSL HEALTHCARELSL Industries, LLCFNY2025-05-15
10661392004624LSL HEALTHCARELSL Industries, LLCFNY2025-04-22
00810180841702DispoSafety Medical Waste Biohazard Bags, 24" x 25.6", 1.18 MIL, 12 GallonDynarex CorporationFNY2025-04-07
00810180841719DispoSafety Medical Waste Biohazard Bags, 36" x 30", 1.2 MIL, 30 GallonDynarex CorporationFNY2025-04-07
00810180841696DispoSafety Medical Waste, Biohazard Bags with Ties,12 Gal,24" x 25.6",0.78 MIL Dynarex CorporationFNY2025-04-07
50198956044898CARDINAL HEALTHCardinal Health 200, LLCFNY2025-04-03
00194613033163MSI Precision Specialty InstrumentsMed Saver, Inc.FNY2025-03-21