AIV FM10839

GUDID M745FM10839

Fetal Transducer Coro Toco Belt

AMERICAN IV PRODUCTS, INC.

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• Primary Device ID: M745FM10839
• NIH Device Record Key: 31d5a5ef-1e07-4626-a785-9dba61ca5f03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AIV
• Version Model Number: FM10839
• Catalog Number: FM10839
• Company DUNS: 181184474
• Company Name: AMERICAN IV PRODUCTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch
• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch
• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch
• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch
• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch
• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch
• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch
• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch
• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch
• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch
• Length: 122.75 Inch
• Height: 0.8 Inch
• Outer Diameter: 2.75 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 14 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M745FM10839 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040392

FDA Product Code

• HFM: Monitor, Uterine Contraction, External (For Use In Clinic)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2022-11-28
• Device Publish Date: 2016-09-02

On-Brand Devices [AIV]

• M745CBSP1: CBSP1 - Pulse Oximeter Adapter Cable
• M745CBHPN1: CBHPN1 - Pulse Oximeter Adapter Cable
• M745CBHPHP1: CBHPHP1 - Pulse Oximeter Adapter Cable
• M745CB10641: CB10641 - Pulse Oximeter Adapter Cable
• M745CB10640: CB10640 - Pulse Oximeter Adapter Cable
• M745CB10639: CB10639 - Pulse Oximeter Adapter Cable
• M745CB10590: CB10590 - Pulse Oximeter Adapter Cable
• M745CB10588: CB10588 - Pulse Oximeter Adapter Cable
• M745CB10587: CB10587 - Pulse Oximeter Adapter Cable
• M745CB10586: CB10586 - Pulse Oximeter Adapter Cable
• M745BC10969: Patient Pendant Bolus Cable
• M745BC10746: Patient Pendant Bolus Cables
• M745CBSP2: CBSP2 - Pulse Oximeter Adapter Cable
• M745BX12812: L02 Smart Label Propofol
• M745BX10469: Assembly Door 1 Baxter
• M745BX10468: Assembly Door 2 Baxter
• M745FM10841: Fetal Transducer Philips Toco
• M745FM10840: Fetal Transducer Coro Toco Button
• M745FM10839: Fetal Transducer Coro Toco Belt