FDA.reportPublic FDA data

Seethoscover® Stethoscope Cover Dispenser

Primary DI
16976393830009
Brand
Seethoscover® Stethoscope Cover Dispenser
Company
Heyuan Youtai Technology Co., Ltd.
Model
Stethoscope Cover Dispenser
Device description
This is a dispenser providing protective stethoscope barrier which is intended to be used as a physical barrier between the patient and the diaphragm/bell of a stethoscope to prevent cross-contamination between patients.
Published
2023-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
16976393830009PackageGS14In Commercial Distribution
06976393830002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697639383000916976393830009
06976393830002069763938300026976393830002

GMDN Terms#

Term, Definition table
TermDefinition
Stethoscope coverAn adhesive film device intended to be used as a physical barrier between the patient and the diaphragm/bell of a stethoscope to prevent cross-contamination between patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-344-1111cs@franklinsports.com

Regulatory Flags#

DUNS number
708816499
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06976393830002Seethoscover® Stethoscope Cover DispenserStethoscope Cover Dispenser2023-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998470578Littmann® Cardiology IV™Solventum US LLCLDE2026-02-03
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M3687111001LABTRONGF HEALTH PRODUCTS, INC.LDE2021-08-24
10885632287459MedichoiceOWENS & MINOR DISTRIBUTION, INC.LDE2020-12-14