FDA.reportPublic FDA data

Argyle

Primary DI
20192253021797
Brand
Argyle
Company
Cardinal Health 200, LLC
Model
8881443009
Catalog number
8881443009-
Device description
Argyle Oral Evacuator Opaque
Published
2022-05-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
EHZEvacuator, oral cavity

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHZEvacuator, Oral CavityDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50192253021798PackageGS15In Commercial Distribution
20192253021797PrimaryGS10
10192253021790Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5019225302179850192253021798
2019225302179720192253021797
1019225302179010192253021790

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction systemAn assembly of devices designed to aspirate water, blood, saliva, and tooth debris from the oral cavity by means of suction, to maintain a clear operative site during dental surgical, professional hygiene, and orthodontic procedures. It consists of an electrically-powered suction pump with a control knob and patient contact devices (typically suction handpiece/tip); collection containers, spittoon, tubing, and amalgam separator are also often included.

Regulatory Flags#

DUNS number
961027315
Device count
100
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10198956037908CARDINAL HEALTH08-3641G08-3641G2026-09-04
10198956210240CARDINAL HEALTHAMN213116EAMN213116E2026-09-04
10198956310933CARDINAL HEALTHANE439532GANE439532G2026-09-04
10198956331891CARDINAL HEALTHSAN13ARBIFSAN13ARBIF2026-09-04
10198956333420CARDINAL HEALTHSANX4IPSSCSANX4IPSSC2026-09-04
10198956359291CARDINAL HEALTHSMA54BGEVCSMA54BGEVC2026-09-04
10198956379084CARDINAL HEALTHSOP33EXMSGSOP33EXMSG2026-09-04
10198956395947CARDINAL HEALTHSOPMIMPMSBSOPMIMPMSB2026-09-04
10198956398467CARDINAL HEALTHSBA44LPCEASBA44LPCEA2026-09-04
10198956415195CARDINAL HEALTHSCVCGOHILHSCVCGOHILH2026-09-04
10198956421462CARDINAL HEALTHSOPMVSAUCJSOPMVSAUCJ2026-09-04
10198956426061CARDINAL HEALTHSCVDKMVOGDSCVDKMVOGD2026-09-04
10198956428102CARDINAL HEALTHSAN13RDEMSSAN13RDEMS2026-09-04
10198956454989CARDINAL HEALTHSOP23KPNLCSOP23KPNLC2026-09-04
10198956462977CARDINAL HEALTHSBA48LCRHCSBA48LCRHC2026-09-04
10198956463394CARDINAL HEALTHSEN23TAPCLSEN23TAPCL2026-09-04
10198956464520CARDINAL HEALTHSMA23GPNVBSMA23GPNVB2026-09-04
10198956465510CARDINAL HEALTH34-3217C34-3217C2026-09-04
10198956468399CARDINAL HEALTHPO1DTHAMQPO1DTHAMQ2026-09-04
10198956468481CARDINAL HEALTHSMAOCGLSTGSMAOCGLSTG2026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194403187AiraAIRA, LLCEHZ2026-08-26
00810194403231AiraAIRA, LLCEHZ2026-08-26
00810194403248AiraAIRA, LLCEHZ2026-08-26
00814005020006TAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502001315P2-90AQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502003703BATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502005115P3AQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502006803BAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502008202BAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502009946P3MQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502010515P2ATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502013615P2AQUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020143FR3QUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020174FR15P2QUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020181FR2QUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020198FR4QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502020446P3ATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502021115P2-1/4QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502022815P3-1/4QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502023556P2QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502024256P3QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502026615P3HOQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502027315P3ATQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502028015P1AQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502030316RSAQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502031015P2TQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502032716RAQUALITY ASPIRATORS, INC.EHZ2025-02-27
00814005020334BE15P3QUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502034115P3TQUALITY ASPIRATORS, INC.EHZ2025-02-27
0081400502035814P3QUALITY ASPIRATORS, INC.EHZ2025-02-27