AccessGUDID - DEVICE: HeraBEAT (07290111520129)

GUDID

Device Identifier (DI) Information

Brand Name: HeraBEAT
Version or Model: HeraBEAT US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PACHBT000US
Company Name: HERA MED LTD

Primary DI Number: 07290111520129
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 600058601 *Terms of Use

Device Description: HeraBEAT US is a hand-held, battery powered audio Doppler device integrated with 2MHz probe, used for detecting and displaying the fetal heart rate (FHR) and FHR sound. The device uses an optical sensor to distinguish between the FHR and the maternal heart rate (MHR) to eliminate “crosstalk” in the FHR display.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
34040	Foetal Doppler system	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNG	Monitor, Ultrasonic, Fetal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191110	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit
Handling Environment Humidity: between 5 and 95 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: af509093-0aa8-4945-b4fb-b1a20cf6c09a
Public Version Date: August 28, 2020
Public Version Number: 1
DI Record Publish Date: August 20, 2020