FDA.reportPublic FDA data

Argyle

Primary DI
50192253024447
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8884724500
Catalog number
8884724500
Device description
Specimen Trap
Published
2024-02-14
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
50192253024447PackageGS150In Commercial Distribution
10192253024449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225302444750192253024447
1019225302444910192253024449

GMDN Terms#

Term, Definition table
TermDefinition
Oral/respiratory tract specimen container IVD, no additive/mediumAn empty covered receptacle containing no additives or media intended to be used in the home and clinical settings for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, oropharyngeal, and/or lower respiratory tract specimen (e.g., sputum) [excluding breath specimen], for in vitro diagnostic investigation. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume40Milliliter

Sterilization Methods#

Method table
Method

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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10192253047967Kendall92339233-2026-05-26
20192253017615Medi-Trace Cadence22661PC22661PC2021-07-29
20192253019992Kendall33547T33547T--2026-05-26
20885380136617CARDINAL HEALTHN8830N88302019-02-07
20885380136624CARDINAL HEALTHN8831N88312019-02-07
20885380136631CARDINAL HEALTHN8832N88322019-02-07
20885380168069CARDINAL HEALTHC3660PPLC3660PPL2019-04-30
10192253045093KendallMK00175MK001752023-06-15
10192253013016Argyle888875001888887500182022-10-26
10192253013023Argyle888875051388887505132022-10-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10852360007024Tobra Graft CompressorTobra Medical, Inc.BYZ2023-05-18
10852360007000Tobra Bone BasketTobra Medical, Inc.BYZ2023-05-15
B325FM990Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20252Environ-mateM D Technologies Inc.BYZ2022-08-05
B325PT20C100Environ-mateM D Technologies Inc.BYZ2022-08-05
04260647240139PHANTOM BONE COLLECTOR, SINGLE-USE, STERILEMorpheus AGBYZ2022-06-28
04260647240122Rebellion Tissue TrapMorpheus AGBYZ2022-06-27
50885632120341MedichoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-10
50885632120334MediChoiceOWENS & MINOR DISTRIBUTION, INC.BYZ2021-06-08
00840117310384Mucus Specimen TrapDYNAREX CORPORATIONBYZ2021-04-22
40080196818625MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
40080196999232MedlineMEDLINE INDUSTRIES, INC.BYZ2021-03-31
10080196997411MEDLINEMEDLINE INDUSTRIES, INC.BYZ2020-10-28
40080196715542MedlineMEDLINE INDUSTRIES, INC.BYZ2020-10-28
10840216101668ASP MEDICALASP GLOBAL, LLCBYZ2020-09-18
00842071129316Explant ExpressAPPLIED MEDICAL TECHNOLOGY, INC.BYZ2020-02-21
00853755004003Hensler Bone PressHensler SurgicalBYZ2019-11-01
00853755004010Hensler Bone CollectorHensler SurgicalBYZ2019-11-01
10884450278731TRAP CAPtain™Merit Medical Systems, Inc.BYZ2019-03-12
00858397006200Disposable BoneBac PressTHOMPSON MISBYZ2018-12-21
00858397006217Disposable BoneBac PressTHOMPSON MISBYZ2018-12-19
16970661241498Andorate®Smartdata Suzhou Co., Ltd.BYZ2018-10-30
16970661241733Andorate®Smartdata Suzhou Co., Ltd.BYZ2018-10-30
00850000126107SAFETRAP TISSUE COLLECTOROto-Med, Inc.BYZ2018-09-21
10080196997404Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BYZ2018-08-28
10884527000074ArgyleCardinal Health, Inc.BYZ2018-06-30