FDA.reportPublic FDA data

SunMed

Primary DI
10889483036983
Brand
SunMed
Company
SUNMED, LLC
Model
6-0027-43
Catalog number
6-0027-43
Device description
DUAL HEAD STETHOSCOPE GREEN
Published
2023-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BZSSTETHOSCOPE HEAD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZSStethoscope HeadAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889483036983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948303698310889483036983

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
069009268
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483222157Ambu900-000-601900-000-6012025-12-19
10889483222164Ambu900-000-602900-000-6022025-12-19
10889483222188Ambu900-000-604900-000-6042025-12-19
10889483222195Ambu900-000-605900-000-6052025-12-19
10889483222201Ambu900-000-606900-000-6062025-12-19
10889483222225Ambu900-000-609900-000-6092025-12-19
10889483222232Ambu900-000-611900-000-6112025-12-19
10889483231494Ambu900-000-614900-000-6142025-12-19
10889483231524Ambu900-000-617900-000-6172025-12-19
10889483231531Ambu900-000-618900-000-6182025-12-19
10889483231586Ambu900-000-624900-000-6242025-12-19
10889483231616Ambu900-000-628900-000-6282025-12-19
10889483565339BALLARD™97012970122025-12-01
10889483565346BALLARD™97014970142025-12-01
10889483565360BALLARD™97020970202025-12-01
10889483565377BALLARD™97021970212025-12-01
10889483155912SunMed4-0050-10M4-0050-10M2023-07-18
10889483225448Septal-H™CP-5410CP-54102025-12-15
10889483225455Septal-H™CP-5500CP-55002025-12-15
10889483230244AirLife™TC-1022TC-10222025-12-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782100209Adscope®AMERICAN DIAGNOSTIC CORPBZS2026-03-30
00634782100216Adscope®AMERICAN DIAGNOSTIC CORPBZS2026-03-30
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00634782100230Adscope®AMERICAN DIAGNOSTIC CORPBZS2026-03-30
00634782100247Adscope®AMERICAN DIAGNOSTIC CORPBZS2026-03-30
00634782100254Adscope®AMERICAN DIAGNOSTIC CORPBZS2026-03-30
00634782100261Adscope®AMERICAN DIAGNOSTIC CORPBZS2026-03-30
00634782100834Adscope®AMERICAN DIAGNOSTIC CORPBZS2026-03-30
00634782101190Adscope®AMERICAN DIAGNOSTIC CORPBZS2026-03-30
00634782099947Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-26
00634782099954Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-26
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00634782099978Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-26
00634782099985Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-26
00634782099992Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-26
00634782099275Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782099350Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782099367Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782099374Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782099886Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782099909Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782099916Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782099930Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782900786Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782900861Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782900878Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782900885Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782901394Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782901417Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15
00634782901424Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-15