FDA.reportPublic FDA data

Argyle

Primary DI
10884521158207
Brand
Argyle
Company
Cardinal Health, Inc.
Model
8881443009
Catalog number
8881443009
Device description
Oral Evacuator,Opaque
Published
2018-06-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
20884521158204PackageGS1500Not in Commercial Distribution
10884521158207PrimaryGS10
30884521158201Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452115820420884521158204
1088452115820710884521158207
3088452115820130884521158201

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.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
100
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30884527016048Devon31145942311459422018-06-29
10884521170728Kendall507250722016-09-24
10884527023240Kerlix258525852018-06-23
10884527023295Kerlix507250722018-06-30
10884521744585Kendall8608U8608U2017-09-07
10884521744608Kendall8617U8617U2017-09-07
10884521744622Kendall8618U8618U2017-09-07
20884521100432SharpSafety8608U8608U2016-09-24
20884521100463Monoject8617U8617U2016-09-24
20884521100470Monoject8618U8618U2016-09-24
40884521023100Monoject31142222311422222016-09-24
10884521020511Monoject888124713788812471372018-06-30
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24
20884527000088Argyle888472450488847245042018-06-30
00884521144227Webcol16818168182018-06-22
10884521189652Monoject1186000444T1186000444T2016-09-24
10884527007110Argyle888816305588881630552016-09-24
20885380173537Curity7267G7267G2019-11-14
20885380173568Curity9024G9024G2019-11-14

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