FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
00810010892263
Brand
CARDINAL HEALTH
Company
AERO-MED, LLC
Model
LCA290
Catalog number
LCA290
Device description
Kidney Stone Transportation Box Kit
Published
2019-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRPTRAY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50810010892268PackageGS112In Commercial Distribution
00810010892263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5081001089226850810010892268
00810010892263008100108922638100108922630810010892263

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kitA collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture, histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered receptacle with or without an additive/medium [e.g., preservation solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.

Regulatory Flags#

DUNS number
194550042
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380210891Aero-MedCA62250CA622502026-06-10
10885380213465Aero-MedCA64850CA648502026-06-10
10192253062595Aero-MedCA28600ACA28600A2022-08-26
10192253062601Aero-MedCA37125CA371252022-08-26
10192253062618Aero-MedCA37875CA378752022-08-26
10192253063561Aero-MedCA44175CA441752023-02-14
10192253063578Aero-MedCA44200CA442002023-02-14
10192253063950Aero-MedCA47175CA471752023-03-15
10192253064001Aero-MedCA48700CA487002023-10-12
10885380193255Aero-MedCA2250CCA2250C2022-07-20
10885380193262Aero-MedCA2275BCA2275B2022-07-20
10885380193538Aero-MedCA44225CA442252022-08-10
10885380193637Aero-MedCA44875CA448752022-08-24
10885380193675Aero-MedCA43775CA437752022-09-09
10885380193828Aero-MedCA44550ACA44550A2022-10-04
10885380193835Aero-MedCA44575ACA44575A2022-10-04
10885380193859Aero-MedCA45525CA455252022-10-14
10885380193965Aero-MedCA46725CA467252022-11-21
10885380194108Aero-MedCA46250CA462502022-12-15
10885380194153Aero-MedCA44900CA449002023-01-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046826380830Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826380939Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413187Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413194Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826413200Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826438180Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826495800Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
04046826495954Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftLRP2026-07-30
00198506092343ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-29
03661219268444LANDANGERLANDANGERLRP2026-07-29
00198506093739ELMED INCORPORATEDELMED INCORPORATEDLRP2026-07-28
00642356005812SteriBestMastel Surgical Inc.LRP2026-07-28
08057639712660Box AdapterMC BIO SRLLRP2026-07-28
10198956414419CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956488236CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956489189CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956492745CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956493025CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956505117CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956509214CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513488CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513716CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513778CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956513815CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956520035CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956523609CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956523715CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956523821CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956527263CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27
10198956531147CARDINAL HEALTHCardinal Health 200, LLCLRP2026-07-27