FDA.reportPublic FDA data

Compact II

Primary DI
00815871020299
Brand
Compact II
Company
Avante
Model
60132II
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGLTransducer, Ultrasonic, Obstetric
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGLTransducer, Ultrasonic, ObstetricObstetrics/Gynecology2
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102140000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102140000FETAL MONITORS, MODELS F2 AND F3Edan Instruments, Inc.2011-01-13HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815871020299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815871020299008158710202998158710202990815871020299

GMDN Terms#

Term, Definition table
TermDefinition
Foetal cardiac monitorA mains electricity (AC-powered) device designed to detect, measure, and display foetal heart activity during the perinatal period. Typically foetal heart rate is measured, but heart valve movement can also be assessed. The device operates noninvasively by: 1) electronically registering and graphically presenting foetal heart sounds; 2) discriminating foetal and maternal electrocardiographic signals obtained from the maternal abdomen with external electrodes; or 3) transmitting and receiving ultrasonic energy into and from the pregnant woman usually by means of continuous wave (Doppler) echoscopy. The device may include an alarm that signals when the heart rate crosses a pre-set threshold.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
502-244-4444devicehelp@dremed.com

Regulatory Flags#

DUNS number
178440426
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815871021647VISION LEDDRE 0615122016-09-23
00815871021685VISION LEDDRE 061512-V2016-09-23
00815871021722VISION EX5DRE 0614122016-09-23
00815871021807Vista LEDDRE 0613122016-09-23
00815871021845Vista LEDDRE 061312-V2016-09-23
00815871022163VISION LEDDRE 0615222017-01-31
00815871022200VISION LEDDRE 061522-V2017-02-01
00815871022248VISION EX5DRE 0614222017-02-01
00815871022286VISION EX5DRE 061422-V2017-02-01
00815871022323Vista LEDDRE 0613222017-02-01
00815871022361Vista LEDDRE 061322-V2017-02-01
00815871020008ASG 12071250ASG2016-09-23
00815871020015ASG 12071250ASGR2016-09-23
00815871020022ASG 2007200ASG2016-09-23
00815871020039ASG 2007200ASGR2016-09-23
00815871020046ASG 3007300ASG2016-09-23
00815871020053ASG 3007300ASGR2016-09-23
00815871021432EG-30070300MB2016-09-23
00815871021449EG-Pro70S4002016-09-23
00815871020107Nasal CO2 Sampling Cannula With O2 DeliveryP03082D2016-09-23

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05051968048233SONICAIDHUNTLEIGH HEALTHCARE LIMITEDHGM2025-12-10
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