FDA.reportPublic FDA data

Argyle

Primary DI
10192253042016
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
31079
Catalog number
31079
Device description
Arygle Suction Catheter Kit with Chimney Valve Single Coil 10 Fr/ Ch
Published
2022-11-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOLCATHETER AND TIP, SUCTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253042014PackageGS150In Commercial Distribution
10192253042016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225304201450192253042014
1019225304201610192253042016

GMDN Terms#

Term, Definition table
TermDefinition
Oropharyngeal secretion specimen suction kitA collection of non-powered devices intended exclusively for professional use to obtain by suction a mucus/sputum specimen from the oropharynx of a neonate for microbiological examination; it might in addition be used to clear mucus from the oropharynx to assist respiration. It consists of a catheter/tube intended to be inserted orally, a piece of suction tubing intended to be attached to an appropriate pump (not included), an empty specimen collection container, and appropriate adapters/lids. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge10French

Regulatory Flags#

DUNS number
961027315
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956232792CARDINAL HEALTHSOP3IOLUTASOP3IOLUTA2026-07-16
10198956260016CARDINAL HEALTHSNE23SPMABSNE23SPMAB2026-07-16
10198956319929CARDINAL HEALTHSAN55TPKFCSAN55TPKFC2026-07-16
10198956326484CARDINAL HEALTH03-1708O03-1708O2026-07-16
10198956334342CARDINAL HEALTHPO21FKEGBPO21FKEGB2026-07-16
10198956335523CARDINAL HEALTHSAN19CCKHOSAN19CCKHO2026-07-16
10198956344020CARDINAL HEALTHSCV73OPBHCSCV73OPBHC2026-07-16
10198956359611CARDINAL HEALTHPO24ARSMCPO24ARSMC2026-07-16
10198956360112CARDINAL HEALTHSMA55DPKCSSMA55DPKCS2026-07-16
10198956364837CARDINAL HEALTHPO54KTGCCPO54KTGCC2026-07-16
10198956368002CARDINAL HEALTHSOPHDUPUBDSOPHDUPUBD2026-07-16
10198956382381CARDINAL HEALTHSCV5DPPUMDSCV5DPPUMD2026-07-16
10198956382930CARDINAL HEALTHSEY48CPOELSEY48CPOEL2026-07-16
10198956388178CARDINAL HEALTHSENHDTAHGDSENHDTAHGD2026-07-16
10198956390546CARDINAL HEALTHSEYHDEYSPBSEYHDEYSPB2026-07-16
10198956392755CARDINAL HEALTHSOPOCPPAEBSOPOCPPAEB2026-07-16
10198956395886CARDINAL HEALTHSAN53EPVSFSAN53EPVSF2026-07-16
10198956400856CARDINAL HEALTH08-0077C08-0077C2026-07-16
10198956408401CARDINAL HEALTHSOPVXEXBMESOPVXEXBME2026-07-16
10198956418431CARDINAL HEALTHSAN69BPKIBSAN69BPKIB2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957568Create BiotechCREATE BIOTECH CO., LTD.JOL2026-07-16
04719874958503Create BiotechCREATE BIOTECH CO., LTD.JOL2026-07-16
00190776396794MillenniumAvalign Technologies, Inc.JOL2026-07-14
00888937033823ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033830ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033847ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033854ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00888937033861ONETRAC™ LXSCoopersurgical, Inc.JOL2026-07-10
00848530109110Suction KitSUNSET HEALTHCARE SOLUTIONS, INC.JOL2026-06-10
10192253038927ArgyleCardinal Health 200, LLCJOL2026-05-07
10080196994137MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-27
10080196035458MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196995561MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-04-02
10080196035434MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
10080196995554MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
10192253039665CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
07613327680720Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680737Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680744Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
07613327680751Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
00840183530990BR Surgical, LLCBR Surgical, LLCJOL2025-09-05
10197344153671MEDLINEMEDLINE INDUSTRIES, INC.JOL2025-05-21
10192253041866ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041873ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253041880ArgyleCardinal Health 200, LLCJOL2025-03-07
10192253038941ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253038958ArgyleCardinal Health 200, LLCJOL2025-02-28
10192253039672ArgyleCardinal Health 200, LLCJOL2024-12-04
10192253003628ArgyleCardinal Health 200, LLCJOL2024-10-09
10192253002928ArgyleCardinal Health 200, LLCJOL2024-09-27