FDA.reportPublic FDA data

Argyle

Primary DI
10884521005372
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8888265322
Catalog number
8888265322
Device description
Stomach Tube Levin Type
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FRQTUBE, LEVINE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRQTube, LevineGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521005379PackageGS150Not in Commercial Distribution
10884521005372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100537920884521005379
1088452100537210884521005372

GMDN Terms#

Term, Definition table
TermDefinition
Nasogastric decompression tubeA sterile, thin, flexible, hollow, single- or double-lumen cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily to reduce the pressure within the gastrointestinal tract, typically aided by connection to an intermittent suction system, that may follow presurgical or postsurgical intestinal occlusion. It may also be used for the delivery of fluids (for irrigation, enteral feeding, and medication administration) typically for the period that gastric decompression is required. This device may be referred to as a nasogastric sump tube or a gastrointestinal decompression tube. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Length48Inch

Storage And Handling#

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

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
10884521015791Dover888762312588876231252016-09-24
10884521153219Monoject118606026511860602652016-09-24
10884527021932Uni-PatchEP84580EP845802016-09-24
20884521012216Monoject888153578888815357882016-09-24
20884521012254Monoject888156018288815601822016-09-24
20884521014159Monoject888151613588815161352016-10-13
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10192253012736ArgyleCardinal Health 200, LLCFRQ2024-06-20
50192253012734ArgyleCardinal Health 200, LLCFRQ2024-06-20
10192253007084ArgyleCardinal Health 200, LLCFRQ2024-04-19
10192253007091ArgyleCardinal Health 200, LLCFRQ2024-04-19
10192253007107ArgyleCardinal Health 200, LLCFRQ2024-04-19
10192253007114ArgyleCardinal Health 200, LLCFRQ2024-04-19
50192253007082ArgyleCardinal Health 200, LLCFRQ2024-04-19
50192253007099ArgyleCardinal Health 200, LLCFRQ2024-04-19
50192253007105ArgyleCardinal Health 200, LLCFRQ2024-04-19
50192253007112ArgyleCardinal Health 200, LLCFRQ2024-04-19
10192253012750ArgyleCardinal Health 200, LLCFRQ2023-11-01
50192253012758ArgyleCardinal Health 200, LLCFRQ2023-11-01
10192253012743ArgyleCardinal Health 200, LLCFRQ2023-10-31
50192253012741ArgyleCardinal Health 200, LLCFRQ2023-10-31
10884521004818ArgyleCardinal Health, Inc.FRQ2016-09-24
10884521004955ArgyleCardinal Health, Inc.FRQ2016-09-24
10884521005112ArgyleCardinal Health, Inc.FRQ2016-09-24
10884521005136ArgyleCardinal Health, Inc.FRQ2016-09-24
10884521005297ArgyleCardinal Health, Inc.FRQ2016-09-24
10884521005389ArgyleCardinal Health, Inc.FRQ2016-09-24
20884521005133ArgyleCardinal Health, Inc.FRQ2016-09-24
20884521004815ArgyleCardinal Health, Inc.FRQ2016-09-24
20884521004952ArgyleCardinal Health, Inc.FRQ2016-09-24
20884521005119ArgyleCardinal Health, Inc.FRQ2016-09-24
20884521005294ArgyleCardinal Health, Inc.FRQ2016-09-24
20884521005379ArgyleCardinal Health, Inc.FRQ2016-09-24
20884521005386ArgyleCardinal Health, Inc.FRQ2016-09-24
00801741045776Bard® Levin TubeC. R. Bard, Inc.FRQ2016-08-16
00801741045783Bard® Levin TubeC. R. Bard, Inc.FRQ2016-08-16
00801741045790Bard® Levin TubeC. R. Bard, Inc.FRQ2016-08-16