FDA.reportPublic FDA data

Argyle

Primary DI
20884521025469
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8888572552
Catalog number
8888572552
Device description
Silicone Thoracic Catheter Straight
Published
2018-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBSCATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBSCatheter, Ventricular, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30884521025466PackageGS110In Commercial Distribution
20884521025469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3088452102546630884521025466
2088452102546920884521025469

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drain, non-bioabsorbableA tube-like, non-bioabsorbable device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp trocar blade, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge28French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Regulatory Flags#

DUNS number
080935429
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521015920Dover20512C20512C2016-09-24
10884521015982Dover20520C20520C2016-09-24
10884521016002Dover20522C20522C2016-10-13
10884521024991Kendall924092402018-06-27
10884521025004Kendall924292422018-06-27
10884521025011Kendall924392432018-06-27
10884521025028Kendall924492442018-06-27
20192253002062Curity21462146-2018-12-12
20884521143064Magellan888183351588818335152016-09-24
10884527007110Argyle888816305588881630552016-09-24
10885380173691Curity6309G6309G2019-11-14
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10884521141148Filac5040835040832016-09-24
10884521165045Kangaroo3881063881062016-09-24
10884521000674Dover35313531-2016-09-24
10884521001046Dover625562552016-09-24
10884521001138Dover825682562016-09-24
10884521001145Dover7016727016722016-09-24
10884521001206Dover7004ICLL7004ICLL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00736239051000Novo VivoGenesis Industries, IncorporatedGBS2023-09-12
14710961935961Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961935978Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961935985Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961935992Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936005Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936012Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936029Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936036Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936043Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936050Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936067Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936074Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936081Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936098Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936104Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936128Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936135Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936142Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936159Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936166Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936173Silicone Thoracic Drain, SF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936180Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936197Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936203Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936210Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936227Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936234Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14710961936241Silicone Thoracic Drain, RF TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15
14711182605572Silicone Thoracic Drain, S TypeFORTUNE MEDICAL INSTRUMENT CORP.GBS2021-12-15