FDA.reportPublic FDA data

LSL HEALTHCARE

Primary DI
10661392013633
Brand
LSL HEALTHCARE
Company
LSL Industries, LLC
Model
2850A
Catalog number
2850A
Device description
Ach Cap Change Kit
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
OWLPeripheral catheter insertion kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWLPeripheral Catheter Insertion KitGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10661392013633PackageGS130In Commercial Distribution
00661392013636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066139201363310661392013633
00661392013636006613920136366613920136360661392013636

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
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
10198956477940CARDINAL HEALTHCardinal Health 200, LLCOWL2026-05-25
20809160517113MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.OWL2026-03-23
30849884007474VYGONVygon CorporationOWL2026-03-06
30849884007320VYGONVygon CorporationOWL2026-02-11
50198956291667CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-16
50198956188127CARDINAL HEALTHCardinal Health 200, LLCOWL2026-01-13
50198956266665CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-25
50198956263558CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-17
50198956257113CARDINAL HEALTHCardinal Health 200, LLCOWL2025-11-13
50198956184457CARDINAL HEALTHCardinal Health 200, LLCOWL2025-09-05
50198956165432CARDINAL HEALTHCardinal Health 200, LLCOWL2025-08-08
20809160486389Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OWL2025-07-22
50197106694808CARDINAL HEALTHCardinal Health 200, LLCOWL2025-06-16
10661392007663LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392007830LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392008561LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392008653LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392011165LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392013480LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392013497LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392013596LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392025759LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392025827LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027548LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027555LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392027678LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392028309LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392037899LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392037981LSL HEALTHCARELSL Industries, LLCOWL2025-05-16
10661392040165LSL HEALTHCARELSL Industries, LLCOWL2025-05-16