FDA.reportPublic FDA data

PremierPro

Primary DI
00811220030278
Brand
PremierPro
Company
PRESTIGE AMERITECH, LTD.
Model
6355
Catalog number
6355
Device description
Dual-Head Stethoscope Pediatric, Gray
Published
2020-08-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10811220030275PackageGS125In Commercial Distribution
00811220030278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081122003027510811220030275
00811220030278008112200302788112200302780811220030278

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical external stethoscope"A non-powered, external listening device designed to be placed on the patient’s skin to listen sounds from the arms, 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 user’s ears. This is a reusable device."

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length30Inch

Contacts#

Phone, Email table
PhoneEmail
1-855-531-7699info@s2s-global.com

Regulatory Flags#

DUNS number
199692794
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811220035433PremierProD5061D50612024-03-08
00811220035440PremierProD5062D50622024-03-08
00811220035457PremierProD5063D50632024-03-08
00811220035464PremierProD5064D50642024-03-08
00811220035471PremierProD5065D50652024-03-08
00852212003269ProKidsFM85030-CCM12016-09-26
00852212003344ProGearFM85011-CCM12016-09-26
00852212003214ProKidsFM850302016-09-26
00852212003801ProGear7410E32026-04-21
00852212003788PrestigePro24512026-03-27
00852212003795PrestigePro24532026-03-27
00818566016454PremierPro24512016-07-15
00818566019783PremierPro24532020-04-28
20818566017479PremierPro531153112020-07-15
20818566017486PremierPro531253122020-07-15
00811220030001PremierPro6604PP6604PP2020-09-08
00811220030018PremierPro6605PP6605PP2020-09-08
00811220030032PremierPro24922020-04-28
00811220030049PremierPro881788172020-08-29
00811220030056PremierPro881888182020-08-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782101848Adscope®AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102098Proscope™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102104Proscope™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102111Proscope™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
00634782102128Adsoft™AMERICAN DIAGNOSTIC CORPLDE2026-08-25
04053755207596GAMMA 3.2 VETHeine Optotechnik GmbH & Co. KGLDE2026-07-22
06972545090454JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
06972545090461JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
16972545090123JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
16972545090130JeashiaZhejiang Honsun Medical Technology Co., Ltd.LDE2026-06-24
00199536933552BluelineTransparent Supply Solutions Ltd.LDE2026-06-15
00634782102258Adscope®AMERICAN DIAGNOSTIC CORPLDE2026-06-02
00199536933507BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933514BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933521BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933538BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933569BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933576BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933583BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933590BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933606BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00634782098384Adscope®AMERICAN DIAGNOSTIC CORPLDE2026-03-30
00197998470479Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470493Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470516Littmann® Classic III™Solventum US LLCLDE2026-02-03
00197998470530Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470554Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470578Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00010939960184Foster & ThriveMCKESSON CORPORATIONLDE2024-06-18
00193489016416MedlineMEDLINE INDUSTRIES, INC.LDE2024-03-05