FDA.reportPublic FDA data

AIV

Primary DI
M745FM10833
Brand
AIV
Company
AMERICAN IV PRODUCTS, INC.
Model
FM10833
Catalog number
FM10833
Device description
Fetal Transducer Coro Ultrasound Belt
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HGMSystem, Monitoring, Perinatal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HGMSystem, Monitoring, PerinatalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040819000TRANSDUCER FOR ULTRASOUND FETAL MONITORING, MODELS FM10833 AND FM10834American I.V. Products, Inc.2004-08-16HGM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M745FM10833PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.8Inch
Length122.75Inch
Outer Diameter2.75Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature14 Degrees Fahrenheit140 Degrees Fahrenheit

Regulatory Flags#

DUNS number
181184474
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M745FM10839AIVFM10839FM108392016-09-02
M745FM10840AIVFM10840FM108402016-09-02
M745FM10841AIVFM10841FM108412016-09-02
M745BX10468AIVBX10468BX104682016-09-24
M745BX10469AIVBX10469BX104692016-09-24
M745BX12812AIVBX12812BX128122016-09-02
M745CBSP2AIVCBSP2CBSP22016-09-02
M745CB10586AIVCB10586CB105862016-09-02
M745CB10587AIVCB10587CB105872016-09-02
M745CB10588AIVCB10588CB105882016-09-02
M745CB10590AIVCB10590CB105902016-09-02
M745CB10639AIVCB10639CB106392016-09-02
M745CB10640AIVCB10640CB106402016-09-02
M745CB10641AIVCB10641CB106412016-09-02
M745CBHPHP1AIVCBHPHP1CBHPHP12016-09-02
M745CBHPN1AIVCBHPN1CBHPN12016-09-02
M745CBSP1AIVCBSP1CBSP12016-09-02
M745BC10746AIVBC10746BC107462016-09-02
M745BC10969AIVBC10969BC109692016-09-02
M745BC10747AIVBC10747BC107472016-09-02

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Primary DI, Brand, Company table
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00860003483565PeriWatch SurveillancePERIGEN INC.HGM2025-11-24
00198953043271CareIntellect PerinatalGe Medical Systems Information Technologies, Inc.HGM2025-11-21