FDA.reportPublic FDA data

Bioseal Inc.

Primary DI
00630094183022
Brand
Bioseal Inc.
Company
BIOSEAL
Model
18302/10
Device description
Neonatal Stethoscope
Published
2023-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
10630094183029PackageGS110In Commercial Distribution
00630094183022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1063009418302910630094183029
00630094183022006300941830226300941830220630094183022

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."

Regulatory Flags#

DUNS number
186968939
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00630094198514Bioseal Inc.19851NS/1002023-12-07
00630094171470Bioseal Inc.17147/012023-09-18
00630094017501Bioseal Inc.1750/502023-09-25
10630094481026Bioseal Inc.DURA102/1002025-05-29
10630094481231Bioseal Inc.DURA123/1002025-05-29
10630094483006Bioseal Inc.DURA300/1002025-05-29
10630094485055Bioseal Inc.DURA505/1002025-05-29
10630094485123Bioseal Inc.DURA512/1002025-05-29
10630094487028Bioseal Inc.DURA702/1002025-05-29
10630094487059Bioseal Inc.DURA705/1002025-05-29
10630094487301Bioseal Inc.DURA730/1002025-05-29
10630094489022Bioseal Inc.DURA902/1002025-05-29
00630094481029Bioseal Inc.DURA102/1002025-05-29
00630094481234Bioseal Inc.DURA123/1002025-05-29
00630094483009Bioseal Inc.DURA300/1002025-05-29
00630094485058Bioseal Inc.DURA505/1002025-05-29
00630094485126Bioseal Inc.DURA512/1002025-05-29
00630094487021Bioseal Inc.DURA702/1002025-05-29
00630094487052Bioseal Inc.DURA705/1002025-05-29
00630094487304Bioseal Inc.DURA730/1002025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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
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00199536933590BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00199536933606BluelineTransparent Supply Solutions Ltd.LDE2026-05-15
00634782098384Adscope®AMERICAN DIAGNOSTIC CORPLDE2026-03-30
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00197998470493Littmann® Classic III™Solventum US LLCLDE2026-02-03
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00197998470530Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470554Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
00197998470578Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
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00193489016416MedlineMEDLINE INDUSTRIES, INC.LDE2024-03-05