FDA.reportPublic FDA data

Pro's Combo V™

Primary DI
00634782597122
Brand
Pro's Combo V™
Company
AMERICAN DIAGNOSTIC CORP
Model
728-619-11AG
Catalog number
728-619-11AG
Device description
Pro's Combo Plus 720/619, Adult, Gray, Disp pkg
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDEStethoscope, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDEStethoscope, ManualCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634782597122PackageGS13In Commercial Distribution
00634782095741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782597122006347825971226347825971220634782597122
00634782095741006347820957416347820957410634782095741

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical stethoscopeA mechanical listening device designed for listening to sounds from the heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the users ears. Mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-4 Degrees Fahrenheit131 Degrees Fahrenheit
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags#

DUNS number
108999095
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634782603045ADC54202542022026-03-31
00634782603052ADC54203542032026-03-31
00634782603069ADC54204542042026-03-31
00634782603076ADC54205542052026-03-31
00634782098384Adscope®603-04W603-04W2026-03-30
00634782100209Adscope®608-12COP608-12COP2026-03-30
00634782100216Adscope®608-12G608-12G2026-03-30
00634782100223Adscope®608-12I608-12I2026-03-30
00634782100230Adscope®608-12ST608-12ST2026-03-30
00634782100247Adscope®608-12MBK608-12MBK2026-03-30
00634782100254Adscope®608-12RGBK608-12RGBK2026-03-30
00634782100261Adscope®608-12RGW608-12RGW2026-03-30
00634782100834Adscope®608-12BK608-12BK2026-03-30
00634782101190Adscope®608-01MBK608-01MBK2026-03-30
00634782101299Adsoft®602-078BK1Q602-078BK1Q2026-03-30
00634782101305Adsoft®602-078PR1Q602-078PR1Q2026-03-30
00634782101312Adsoft®602-078TQ1Q602-078TQ1Q2026-03-30
00634782101329Adsoft®602-078G1Q602-078G1Q2026-03-30
00634782101336Adsoft®602-078Y1Q602-078Y1Q2026-03-30
00634782101343Adsoft®602-078P1Q602-078P1Q2026-03-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970784670222Rhino Rescuewenzhou dongfang medical instrument co.,ltdLDE2026-03-24
00197998470486Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470509Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470523Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470547Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470561Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470585Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00767056422018MabisD-M-S HOLDINGS, INC.LDE2025-12-29
06975185470136LightningWenzhou Kangshun Medical Devices CO.,LTDLDE2025-09-15
06975185470150LightningWenzhou Kangshun Medical Devices CO.,LTDLDE2025-09-15
06974546523160TealmedNingbo Tealmed Emergency Products Co., Ltd.LDE2025-07-21
04053755203048GAMMA 3.2Heine Optotechnik GmbH & Co. KGLDE2025-07-17
06974546523153TealmedNingbo Tealmed Emergency Products Co., Ltd.LDE2025-05-12
06975185470037AcmeWenzhou Kangshun Medical Devices CO.,LTDLDE2025-03-05
04030155004819Colorscop-duo stethoscope, pinkKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155004970Standard-Prestige stethoscope stainless steel, blackKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155005076Planet double stethoscope according to FassbenderKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155005168Ear tips, black, Ø 5,5 mm, PU: 10 pcs. W. white turned partsKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155011695Stethoscope double tube, black, length 60cmKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
04030155019448Planet Air stethoscopeKirchner & Wilhelm GmbH + Co KGLDE2023-09-12
10889483005378SunMedSUNMED, LLCLDE2023-08-01
00888277722388MedlineMEDLINE INDUSTRIES, INC.LDE2023-01-21
00634782600402Adscope®AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782600990Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601003Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601010Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601027Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601034Pro's Combo™AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601072Adscope®AMERICAN DIAGNOSTIC CORPLDE2023-01-11
00634782601089Adscope®AMERICAN DIAGNOSTIC CORPLDE2023-01-11