FDA.reportPublic FDA data

AIV

Primary DI
M745FM10839
Brand
AIV
Company
AMERICAN IV PRODUCTS, INC.
Model
FM10839
Catalog number
FM10839
Device description
Fetal Transducer Coro Toco Belt
Published
2016-09-02
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
HFMMonitor, Uterine Contraction, External (For Use In Clinic)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HFMMonitor, Uterine Contraction, External (For Use In Clinic)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040392000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040392000TRANSDUCERS FOR ULTRASOUND AND TOCODYNAMOMETER FETAL MONITORINGAmerican I.V. Products, Inc.2004-09-14HFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M745FM10839PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tocodynamometer probeA pressure transducer intended to be placed on the abdomen of a labouring woman to convert uterine birthing contractions to electrical signals; the signals are typically displayed by a cardiotocograph (CTG). This is a reusable device.

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

Sterilization Methods#

Method table
Method

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
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
M745BC10925AIVBC10925BC109252016-09-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884838093188Avalon Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093195Avalon Ultrasound TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093201Avalon ECG/IUP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093218Avalon Toco MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
00884838093225Avalon Toco+ TransducerPhilips Medizin Systeme Böblingen GmbHHFM2021-03-08
20884838059324Avalon Fetal & Maternal PatchPhilips Medical Systems HsgHFM2020-05-25
00884838068179Avalon CL Fetal & Maternal PodPhilips Medizin Systeme Böblingen GmbHHFM2020-05-22
00840682142571TOCO TRANSDUCERWIPRO GE HEALTHCARE PRIVATE LIMITEDHFM2018-11-01
00884838034235Avalon CL Toco+ MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-19
00884838002715Avalon TOCO+ TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-03
00884838021471Avalon TOCO MP TransducerPhilips Medizin Systeme Böblingen GmbHHFM2016-10-03
M745FM10840AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
M745FM10841AIVAMERICAN IV PRODUCTS, INC.HFM2016-09-02
00814247020284Koala Toco®CLINICAL INNOVATIONS, LLCHFM2016-09-01
20814247020288Koala Toco®CLINICAL INNOVATIONS, LLCHFM2016-09-01
B249VA000380FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA000381FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA001060FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA001061FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002020FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002030FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002190FEATHERLITE AQUAPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA002191FEATHERLITE AQUAPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003100FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003101FEATHERLITE TOCOPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003110FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003111FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003120FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
B249VA003121FEATHERLITE TOCO PLUSPARKER-HANNIFIN CORPORATIONHFM2016-08-18
00840682104111N/AWIPRO GE HEALTHCARE PRIVATE LIMITEDHFM2016-06-24