FDA.reportPublic FDA data

Argyle

Primary DI
20884527019363
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8888270603
Catalog number
8888270603
Device description
5-in-1 Bubble Connector,Polyethylene
Published
2018-06-27
Public version status
Update
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
GCDCONNECTOR, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCDConnector, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884527019363PackageGS1100In Commercial Distribution
10884527019366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452701936320884527019363
1088452701936610884527019366

GMDN Terms#

Term, Definition table
TermDefinition
Non-ISO80369-standardized small-bore multichannel connector, single-useA small, non-powered, noninvasive, small-bore tubular connector with three or more connections (typically barbed, bayonet, conical, threaded and/or non-Luer-slip), none of which are designed according to ISO 80369 (standard for small-bore connectors for liquids and gases), intended to connect three or more luminal devices (e.g., tubing, container) with each other during a medical procedure. It is typically T-, Y- or cross-shaped; it does not incorporate a filter, valve, clamp, tubing or puncturing component, and is not a dedicated gas-line connector. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
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
10884521000308Dover20042004-2016-09-24
10884521000681Dover202020202016-09-24
10884521001039Dover20142014-2016-09-24
10884521001053Dover20182018-2016-09-24
10884521001084Dover625662562016-09-24
10884521009455Dover34203420-2016-09-24
10884521009585Dover3450LF3450LF2016-09-24
10884521082403Curity260026002018-06-29
10884521084216Kerlix26719267192018-06-29
10884521158863Kendall2419CD2419CD2018-06-28
10884527020782Curity260126012018-06-29
10884521174917Devon31141206311412062016-09-24
10884527009954Kendall30781747307817472018-06-23
10884521015791Dover888762312588876231252016-09-24
30884527004847KendallES82417ES82417-2016-09-24
20884521152134Covidien3114574431145744-2016-09-24
30884521024841Kendall923692362018-06-30
10884521138247Devon31146891311468912016-09-24
10884521138261Devon31146893311468932016-09-24
10884521154094Devon31146894311468942016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704937223PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937377PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937384PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937391PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937407PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-08
14026704937339PLEUR-EVACTELEFLEX INCORPORATEDGCD2026-05-07
14026704911858PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-04-29
10192253042900ArgyleCardinal Health 200, LLCGCD2025-03-07
10192253042832ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042856ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042863ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042870ArgyleCardinal Health 200, LLCGCD2025-02-27
10192253042887ArgyleCardinal Health 200, LLCGCD2025-02-27
14026704933126PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933133PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933140PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
14026704933157PLEUR-EVACTELEFLEX INCORPORATEDGCD2025-01-28
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14710961934971Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
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14710961935022Silicone Flat DrainFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
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14710961935046Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935053Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935060Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935077Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31
14710961935084Silicone Flat Drain KitFORTUNE MEDICAL INSTRUMENT CORP.GCD2022-01-31