FDA.reportPublic FDA data

Argyle

Primary DI
10884521025547
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8888573568
Catalog number
8888573568
Device description
Silicone Mediastinal Drain
Published
2018-06-30
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

Contact Domains#

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
20884521025544PackageGS110In Commercial Distribution
10884521025547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452102554420884521025544
1088452102554710884521025547

GMDN Terms#

Term, Definition table
TermDefinition
Pericardiocentesis catheterA flexible tube designed for the drainage of effusion from the pericardial sac (the pericardium). It typically consists of a thin walled, flexible, plastic [e.g., polyethylene (PE)] tube with a J-shaped distal tip perforated with multiple holes in both its convex and concave sides. It is introduced percutaneously into the pericardium, anchored in place, and connected to a water-seal drainage system. It can be left in situ for some days or weeks during the treatment of cardiac tamponade and can be used for the irrigation/instillation of drugs (e.g., antibiotics, cytotoxic agents) into the pericardium. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge34French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry;AVOID DIRECT SUNLIGHT

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011648116Automatic Continuous Effusion System (ACES) KitPleural Dynamics, Inc.GBS2026-07-13
00860011648109Automatic Continuous Effusion Shunt (ACES) SystemPleural Dynamics, Inc.GBS2026-05-21
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