FDA.reportPublic FDA data

Argyle

Primary DI
20884521005294
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8888265314
Catalog number
8888265314
Device description
Stomach Tube Levin Type
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
20884521005294PackageGS150In Commercial Distribution
10884521005297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452100529420884521005294
1088452100529710884521005297

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 Gauge12French
Length48Inch

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
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
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
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