FDA.reportPublic FDA data

SunMed

Primary DI
20889483172640
Brand
SunMed
Company
SUNMED, LLC
Model
6-1030-53
Catalog number
6-1030-53
Device description
DIAGNOSTIC TRAINING KIT PRO
Published
2023-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
20889483172640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948317264020889483172640

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
Kit
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
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
10889483033289SunMed9-0210-019-0210-012024-03-12
10889483564578BALLARD™221036-5227036-52025-11-21
10889483040218SunMed5-0236-315-0236-312023-03-21
10889483221150AirLife™093709372025-12-18
10889483221181Vital Signs™8809-W8809-W2025-12-23
10889483221747AirLife™026202622025-12-19
10889483222027Co2 Easy5621342026-03-31
10889483222034Pedi Co2 Easy5621352026-03-31
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
10889483222393AirLife™056205622025-12-18

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
00634782100223Adscope®AMERICAN DIAGNOSTIC CORPBZS2026-03-30
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
00634782099961Adscope®AMERICAN DIAGNOSTIC CORPBZS2023-12-26
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