FDA.report

Welch Allyn, Inc.

Primary DI
00732094115147
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901039
Catalog number
5079-321S
Device description
Welch Allyn Harvey DLX Cardiology Stethoscope with Stainless Steel Triple-Head Chestpiece (Low-Frequency Bell, Adult Diaphragm, and Pediatric Diaphragm), Dual Lumen Latex-Free Tubing, Harvey Heart Sounds CD, Harvey DLX Accessory Kit (#5079-315); 28 in/71.1 cm; Black
Published
2020-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LDESTETHOSCOPE, MANUAL

Product Code Classifications

CodeDeviceSpecialtyClass
LDEStethoscope, ManualCardiovascular1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094115147PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094115147007320941151477320941151470732094115147

GMDN Terms

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

Contacts

PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags

DUNS number
198227881
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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