MAHURKAR Elite

GUDID 20884521125626

Acute Dual Lumen Catheter Kit,High Flow Pre-Curved,13.5 Fr/Ch (4.5 mm) x 13 cm

Covidien LP

Double-lumen haemodialysis catheter, nonimplantable

• Primary Device ID: 20884521125626
• NIH Device Record Key: cb68bcf7-0ddb-42de-aea3-a2629e52ed81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAHURKAR Elite
• Version Model Number: 8888213213
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Dimensions

• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French
• Length: 13 Centimeter
• Catheter Gauge: 13.5 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight.
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521125629 [Primary]
GS1	20884521125626 [Package]; Contains: 10884521125629; Package: PACK_OR_INNER_PACK [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120674

FDA Product Code

• MPB: CATHETER, HEMODIALYSIS, NON-IMPLANTED

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-05-31
• Device Publish Date: 2016-04-04

On-Brand Devices [MAHURKAR Elite]

• 10884521126268: Acute Dual Lumen Catheter Tray,High Flow Curved Extensions with IC* Safety Components,13.5 Fr/Ch
• 10884521126251: Acute Dual Lumen Catheter Tray,High Flow Curved Extensions with IC* Safety Components,13.5 Fr/Ch
• 10884521126015: Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Safety Components,13.5 Fr/
• 10884521127784: Acute Triple Lumen Catheter Tray,Curved Extensions with IC* Safety Components,12.5 Fr/Ch (4.2 mm
• 10884521126541: Acute Dual Lumen Catheter Tray,Curved Extensions with IC* Safety Components,12 Fr/Ch (4.0 mm) x
• 10884521126510: Acute Dual Lumen Catheter Tray,Curved Extensions with IC* Safety Components,12 Fr/Ch (4.0 mm) x
• 10884521126442: Acute Dual Lumen Catheter Tray,Straight Extensions with IC* Safety Components,12 Fr/Ch (4.0 mm)
• 10884521126435: Acute Dual Lumen Catheter Tray,Straight Extensions with IC* Safety Components,12 Fr/Ch (4.0 mm)
• 10884521126428: Acute Dual Lumen Catheter Tray,Straight Extensions with IC* Safety Components,12 Fr/Ch (4.0 mm)
• 10884521126299: Acute Dual Lumen Catheter Tray,High Flow Curved Extensions with IC* Safety Components,13.5 Fr/Ch
• 10884521126046: Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Safety Components,13.5 Fr/
• 10884521126022: Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Safety Components,13.5 Fr/
• 10884521788732: Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC* Safety Components
• 10884521127777: Acute Triple Lumen Catheter Tray,Curved Extensions with IC* Safety Components,12.5 Fr/Ch (4.2 mm
• 10884521127760: Acute Triple Lumen Catheter Tray,Curved Extensions with IC* Safety Components,12.5 Fr/Ch (4.2 mm
• 10884521126701: Acute Dual Lumen Catheter Tray,Pre-Curved with IC* Safety Components,12 Fr/Ch (4.0 mm) x 16 cm
• 10884521126695: Acute Dual Lumen Catheter Tray,Pre-Curved with IC* Safety Components,12 Fr/Ch (4.0 mm) x 13 cm
• 10884521126671: Acute Dual Lumen Catheter Tray,High Flow Pre-Curved with IC* Safety Components,13.5 Fr/Ch (4.5 m
• 10884521126664: Acute Dual Lumen Catheter Tray,High Flow Pre-Curved with IC* Safety Components,13.5 Fr/Ch (4.5 m
• 10884521126459: Acute Dual Lumen Catheter Tray,Straight Extensions with IC* Safety Components,12 Fr/Ch (4.0 mm)
• 10884521126411: Acute Dual Lumen Catheter Tray,Straight Extensions with IC* Safety Components,12 Fr/Ch (4.0 mm)
• 10884521126305: Acute Dual Lumen Catheter Tray,High Flow Curved Extensions with IC* Safety Components,13.5 Fr/Ch
• 10884521126039: Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Safety Components,13.5 Fr/
• 10884521126534: Acute Dual Lumen Catheter Tray,Curved Extensions with IC* Safety Components,12 Fr/Ch (4.0 mm) x
• 10884521126718: Acute Dual Lumen Catheter Tray,Pre-Curved with IC* Safety Components,12 Fr/Ch (4.0 mm) x 20 cm
• 10884521126657: Acute Dual Lumen Catheter Tray,High Flow Pre-Curved with IC* Safety Components,13.5 Fr/Ch (4.5 m
• 10884521126527: Acute Dual Lumen Catheter Tray,Curved Extensions with IC* Safety Components,12 Fr/Ch (4.0 mm) x
• 10884521126008: Acute Dual Lumen Catheter Tray,High Flow Straight Extensions with IC* Safety Components,13.5 Fr/
• 20884521125787: Acute Dual Lumen Catheter,Curved Extensions with 2 Sealing Caps,12 Fr/Ch (4.0 mm) x 16 cm
• 20884521125770: Acute Dual Lumen Catheter,Curved Extensions with 2 Sealing Caps,12 Fr/Ch (4.0 mm) x 13 cm
• 20884521125688: Acute Dual Lumen Catheter,Straight Extensions with 2 Sealing Caps,12 Fr/Ch (4.0 mm) x 24 cm
• 20884521125664: Acute Dual Lumen Catheter,Straight Extensions with 2 Sealing Caps,12 Fr/Ch (4.0 mm) x 16 cm
• 20884521125510: Acute Dual Lumen Catheter,High Flow Pre-Curved with 2 Sealing Caps,13.5 Fr/Ch (4.5 mm) x 16 cm
• 20884521125497: Acute Dual Lumen Catheter,High Flow Pre-Curved with 2 Sealing Caps,13.5 Fr/Ch (4.5 mm) x 13 cm
• 20884521125343: Acute Dual Lumen Catheter,High Flow Curved Extensions with 2 Sealing Caps,13.5 Fr/Ch (4.5 mm) x
• 20884521125312: Acute Dual Lumen Catheter,High Flow Straight Extensions with 2 Sealing Caps,13.5 Fr/Ch (4.5 mm)
• 20884521125305: Acute Dual Lumen Catheter,High Flow Straight Extensions with 2 Sealing Caps,13.5 Fr/Ch (4.5 mm)
• 20884521125220: Acute Dual Lumen Catheter,High Flow Straight Extensions with 2 Sealing Caps,13.5 Fr/Ch (4.5 mm)
• 10884521788619: Acute Dual Lumen Catheter Tray Curved Extensions with IC* Safety Components
• 10884521788565: Acute Dual Lumen Catheter Tray Straight Extensions with IC* Safety Components
• 10884521788558: Acute Dual Lumen Catheter Tray Straight Extensions with IC* Safety Components
• 10884521788541: Acute Dual Lumen Catheter Tray Straight Extensions with IC* Safety Components
• 10884521788442: Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC* Safety Components
• 10884521788725: Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC* Safety Components
• 10884521788695: Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC* Safety Components
• 10884521788688: Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC* Safety Components
• 10884521788602: Acute Dual Lumen Catheter Tray Curved Extensions with IC* Safety Components
• 10884521788480: Acute Dual Lumen Catheter Tray High Flow Curved Extensions with IC* Safety Components
• 10884521788428: Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC* Safety Components
• 10884521788459: Acute Dual Lumen Catheter Tray High Flow Straight Extensions with IC* Safety Components