FDA.reportPublic FDA data

Argyle

Primary DI
10884521005136
Brand
Argyle
Company
Cardinal Health, Inc.
Model
155713
Catalog number
155713
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
20884521005133PackageGS150Not in Commercial Distribution
10884521005136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100513320884521005133
1088452100513610884521005136

GMDN Terms#

Term, Definition table
TermDefinition
Nasogastric/orogastric tubeA sterile, hollow cylinder that can be introduced into the gastrointestinal (GI) tract both nasally and orally for feeding and/or aspiration. It is made of plastic or rubber and is available in a variety of designs and lengths. Some types are a simple rubber tube with a glass window; other types can be radiopaque to assist accurate placement, have multiple flow-through eyes, and dual connectors (e.g., one for suction and the other for irrigation/feeding). Other uses can be to decompress the stomach, withdraw specimens for diagnostic analysis, administer medications, and for irrigation of the stomach to treat upper gastrointestinal (UGI) bleeding. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge18French
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521156159Monoject8934CRS8934CRS2017-01-06
10884521156173Monoject8985CRH8985CRH2017-01-07
20884521156200Monoject8985CRS8985CRS2017-01-07
20884521156217Monoject8989CRH8989CRH2017-01-07
10884521010444Monoject888147127388814712732018-06-30
10884521157682Curity2022A2022A2018-06-22
10884521195547Monoject1180327114E1180327114E2018-06-22
20884521195506Monoject1180323114E1180323114E2018-06-22
40884521010438Monoject888147123288814712322018-06-30
40884521018311SharpSafety8535Y8535Y2017-01-07
40884521018380Monoject8970Y8970Y2017-01-06
10884521742390Monoject888135278888813527882019-05-17
10884527006786Monoject888135278888813527882016-09-24
10884521131897VistecVS4332VS43322018-06-30
30884527004755Kendall50007363500073632016-09-24
10884521028258Kangaroo6746696746692019-11-27
10884521069343Dover888766526288876652622016-10-20
10884527010349KendallMK06860MK068602016-09-24
10884527022113Kendall3353433534-2016-09-24
10885380173691Curity6309G6309G2019-11-14

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
10884521005297ArgyleCardinal Health, Inc.FRQ2016-09-24
10884521005372ArgyleCardinal 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