FDA.reportPublic FDA data

Sprague Rappaport Stethoscope Amplifies Heart & Lung Sounds,Black

Primary DI
00616784713526
Brand
Sprague Rappaport Stethoscope Amplifies Heart & Lung Sounds,Black
Company
Dynarex Corporation
Model
7135
Device description
Complete Kit Includes: 3 sets of eartips, Large & small diaphragm, Diaphragm removal tool, Adult, pediatric & infant bells, Dual tubing that transmits faint sounds.
Published
2021-04-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00616784713533PackageGS120In Commercial Distribution
00616784713526PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784713533006167847135336167847135330616784713533
00616784713526006167847135266167847135260616784713526

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
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

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