FDA.reportPublic FDA data

LSL HEALTHCARE

Primary DI
10661392011950
Brand
LSL HEALTHCARE
Company
LSL Industries, LLC
Model
8250
Catalog number
8250
Device description
Fracture Female Bed Pan
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
FOBBEDPAN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOBBedpanGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10661392011950PackageGS112In Commercial Distribution
00661392011953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066139201195010661392011950
00661392011953006613920119536613920119530661392011953

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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00199284374782EnviroCare PouchEnviroCare Health Limited Liability CompanyFOB2025-06-30
10661392012582LSL HEALTHCARELSL Industries, LLCFOB2025-05-16
00860010353271EnviroSorb® CommodeShield™LDI Solutions, LLCFOB2025-03-04
00860010353288EnviroSorb® CommodeShield™LDI Solutions, LLCFOB2025-03-04
00860010353264EnviroSorb® CommodeShield™LDI Solutions, LLCFOB2025-03-03
10818323021759ViveVIVE HEALTH LLCFOB2024-01-12
10818323026709ViveVIVE HEALTH LLCFOB2024-01-12
10818323026716ViveVIVE HEALTH LLCFOB2024-01-12
10810041989441ViveVIVE HEALTH LLCFOB2023-11-13
10810041989724ViveVIVE HEALTH LLCFOB2023-11-13
10810113574636ViveVIVE HEALTH LLCFOB2023-11-13
10810113574643ViveVIVE HEALTH LLCFOB2023-11-13
10810113574650ViveVIVE HEALTH LLCFOB2023-11-13
10810113574667ViveVIVE HEALTH LLCFOB2023-11-13
10810113574780ViveVIVE HEALTH LLCFOB2023-11-13
10810113574797ViveVIVE HEALTH LLCFOB2023-11-13
50628725096358CHSStadco PolyProducts IncFOB2023-07-06
50628725096365CHSStadco PolyProducts IncFOB2023-07-06
50628725096372CHSStadco PolyProducts IncFOB2023-07-06
50628725096389CHSStadco PolyProducts IncFOB2023-07-06
00628725096698CHSStadco PolyProducts IncFOB2023-07-06
00628725096704CHSStadco PolyProducts IncFOB2023-07-06
00628725096735CHSStadco PolyProducts IncFOB2023-07-06
50628725096747CHSStadco PolyProducts IncFOB2023-07-06
50628725096341CHSStadco PolyProducts IncFOB2023-07-04
10810041989458ViveVIVE HEALTH LLCFOB2023-06-30
10810113573240VIVEVIVE HEALTH LLCFOB2023-06-30
00733657188370BARIATRIC BED PANALIMED, INC.FOB2022-12-01
00733657231618COMFORTABLE BED PANALIMED, INC.FOB2022-12-01