FDA.reportPublic FDA data

Argyle

Primary DI
10192253050783
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8886864304
Catalog number
8886864304
Device description
Luki Tube Specimen Collection Device 8mL 3-1/4 in. (8.3 cm)
Published
2026-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BYZTRAP, STERILE SPECIMEN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BYZTrap, Sterile SpecimenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20192253050780PackageGS112In Commercial Distribution
50192253050781PackageGS14In Commercial Distribution
10192253050783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019225305078020192253050780
5019225305078150192253050781
1019225305078310192253050783

GMDN Terms#

Term, Definition table
TermDefinition
Thoracic suction pumpAn electrically-powered, portable device, which may include noninvasive accessories, intended to generate negative pressure specifically for aspiration of the pleural cavity and/or mediastinum. It is a dedicated device intended to remove fluids (e.g., blood), secretions, and air to allow for the normal expansion/function of the lungs and/or mediastinum. The device may incorporate a display and may include collection containers or tubing; it does not include patient contact devices (e.g., catheter).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0
Total Volume0

Regulatory Flags#

DUNS number
961027315
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253024456Argyle888472450488847245042026-10-09
10192253024463Argyle888825860888882586082026-10-09
10192253050790Argyle888686460488868646042026-10-09
10192253050806Argyle888825736088882573602026-10-09
10192253050813Argyle888825737888882573782026-10-09
10192253050820Argyle888825738688882573862026-10-09
10192253050837Argyle888825746988882574692026-10-09
10192253050844Argyle888825747788882574772026-10-09
10192253050851Argyle888825748588882574852026-10-09
10192253050868Argyle888825752788882575272026-10-09
10192253050875Argyle888825753588882575352026-10-09
10192253050882Argyle888825755088882575502026-10-09
10885380214813DermaceaWD6112WD61122026-10-09
10885380214820DermaceaWD6113WD61132026-10-09
10885380214837DermaceaWD6114WD61142026-10-09
10885380214844DermaceaWD6115WD61152026-10-09
10885380214851DermaceaWD6116WD61162026-10-09
20885380157339FLEXAL88RT01XS88RT01XS2018-09-21
20885380157346FLEXAL88RT02S88RT02S2018-09-21
20885380157353FLEXAL88RT03M88RT03M2018-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253024456ArgyleCardinal Health 200, LLCBYZ2026-10-09
10192253050806ArgyleCardinal Health 200, LLCBYZ2026-10-09
10192253050813ArgyleCardinal Health 200, LLCBYZ2026-10-09
10192253050820ArgyleCardinal Health 200, LLCBYZ2026-10-09
10192253050837ArgyleCardinal Health 200, LLCBYZ2026-10-09
10192253050844ArgyleCardinal Health 200, LLCBYZ2026-10-09
10192253050851ArgyleCardinal Health 200, LLCBYZ2026-10-09
10192253050868ArgyleCardinal Health 200, LLCBYZ2026-10-09
10192253050875ArgyleCardinal Health 200, LLCBYZ2026-10-09
10192253050882ArgyleCardinal Health 200, LLCBYZ2026-10-09
06970057554396CITECChangzhou Intl. Trade & Enterprises Cooperative Co., Ltd.BYZ2026-07-27
06975238205746CITECChangzhou Intl. Trade & Enterprises Cooperative Co., Ltd.BYZ2026-07-27
06970057578286Polyp TrapsJiangsu Vedkang Medical Science and Technology Co.,Ltd.BYZ2026-05-22
00861092002613CeaLogic Specimen Collection KitRECIBIO, INC.BYZ2026-03-01
04260647240382OsteoPointMorpheus AGBYZ2024-11-26
06975238202561CITECChangzhou Intl. Trade & Enterprises Cooperative Co., Ltd.BYZ2024-07-12
10192253024449ArgyleCardinal Health 200, LLCBYZ2024-02-14
50192253024447ArgyleCardinal Health 200, LLCBYZ2024-02-14
00852360007027Tobra Graft CompressorTobra Medical, Inc.BYZ2023-05-18
10852360007024Tobra Graft CompressorTobra Medical, Inc.BYZ2023-05-18
00852360007003Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
10852360007000Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
B325FM991Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20101Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C101Environ-mateM D Technologies Inc.BYZ2022-08-05
B325FM990Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20252Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C100Environ-mateM D Technologies Inc.BYZ2022-08-05
00860006413903Bone dust trapRIM Medical Technologies IncorporatedBYZ2022-07-10
04260647240139PHANTOM BONE COLLECTOR, SINGLE-USE, STERILEMorpheus AGBYZ2022-06-28