FDA.report

MedaSonics

Primary DI
00888937002614
Brand
MedaSonics
Company
Coopersurgical, Inc.
Model
101-0327-010
Device description
First Beat Fetal Doppler with Speaker; without Display
Published
2016-07-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications

CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions

SubmissionSupplement
K961116000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K961116000FIRST BEAT/CARDIO BEAT/CALCMedasonics, Inc.1996-08-08IYO

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888937002614PrimaryGS10

GMDN Terms

TermDefinition
Foetal Doppler systemA portable, hand-held, battery-powered device assembly consisting of a measuring and display unit and an attached probe or interchangeable probes designed to noninvasively detect foetal heart beats using ultrasound/Doppler technology. The heart beats are typically conveyed audibly via the measuring/display unit and attached probe which is applied to the surface of the pregnant woman's abdomen. The device aids in determining foetal viability.

Sterilization Methods

Method

Regulatory Flags

DUNS number
801895244
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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