GamCath HighFlow Dolphin Catheter 114035

GUDID 37332414110780

Short-term use to obtain vasular access in patients with acute or chronic renal failure. The GamCath HighFlow Dolphin Catheter combines the GamCath Hi

Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH

Double-lumen haemodialysis catheter, nonimplantable

• Primary Device ID: 37332414110780
• NIH Device Record Key: 82841c64-6481-4b55-924b-6d81e3426aac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GamCath HighFlow Dolphin Catheter
• Version Model Number: GAMCATH MS-GDHC-1315J A
• Catalog Number: 114035
• Company DUNS: 333802754
• Company Name: Gambro Kathetertechnik Hechingen - Zweigniederlassung der Gambro Dialysatoren GmbH
• 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: 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: Medinfo_medproducts@baxter.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French
• Device Size Text, specify: 0
• Length: 150 Millimeter
• Catheter Gauge: 13 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.
• Storage Environment Temperature: Between 0 and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Keep away from sunlight.

Device Identifiers

Device Issuing Agency	Device ID
GS1	07332414110789 [Primary]
GS1	37332414110780 [Package]; Contains: 07332414110789; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100451

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-07

On-Brand Devices [GamCath HighFlow Dolphin Catheter]

• 37332414110797: Short-term use to obtain vasular access in patients with acute or chronic renal failure. The Gam
• 37332414110780: Short-term use to obtain vasular access in patients with acute or chronic renal failure. The Gam
• 37332414110773: Short-term use to obtain vasular access in patients with acute or chronic renal failure. The Gam
• 37332414110766: Short-term use to obtain vasular access in patients with acute or chronic renal failure. The Gam
• 37332414110711: Short-term use to obtain vasular access in patients with acute or chronic renal failure. The Gam
• 37332414110704: Short-term use to obtain vasular access in patients with acute or chronic renal failure. The Gam
• 37332414110698: Short-term use to obtain vasular access in patients with acute or chronic renal failure. The Gam
• 37332414110681: Short-term use to obtain vasular access in patients with acute or chronic renal failure. The Gam
• 37332414110674: Short-term use to obtain vasular access in patients with acute or chronic renal failure. The Gam
• 37332414110667: Short-term use to obtain vasular access in patients with acute or chronic renal failure. The Gam