AIV FM10839

GUDID M745FM10839

Fetal Transducer Coro Toco Belt

AMERICAN IV PRODUCTS, INC.

Tocodynamometer probe
Primary Device IDM745FM10839
NIH Device Record Key31d5a5ef-1e07-4626-a785-9dba61ca5f03
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIV
Version Model NumberFM10839
Catalog NumberFM10839
Company DUNS181184474
Company NameAMERICAN IV PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch
Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch
Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch
Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch
Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch
Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch
Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch
Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch
Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch
Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch
Length122.75 Inch
Height0.8 Inch
Outer Diameter2.75 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
Storage Environment TemperatureBetween 14 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM745FM10839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HFMMonitor, Uterine Contraction, External (For Use In Clinic)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-11-28
Device Publish Date2016-09-02

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M745CB10639CB10639 - Pulse Oximeter Adapter Cable
M745CB10590CB10590 - Pulse Oximeter Adapter Cable
M745CB10588CB10588 - Pulse Oximeter Adapter Cable
M745CB10587CB10587 - Pulse Oximeter Adapter Cable
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M745BC10969Patient Pendant Bolus Cable
M745BC10746Patient Pendant Bolus Cables
M745CBSP2CBSP2 - Pulse Oximeter Adapter Cable
M745BX12812L02 Smart Label Propofol
M745BX10469Assembly Door 1 Baxter
M745BX10468Assembly Door 2 Baxter
M745FM10841Fetal Transducer Philips Toco
M745FM10840Fetal Transducer Coro Toco Button
M745FM10839Fetal Transducer Coro Toco Belt

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