AccuCath PCK00009

GUDID 10801741218047

Catheter Placement Kit

Bard Access Systems, Inc.

Peripheral vascular intervention infusion catheter

• Primary Device ID: 10801741218047
• NIH Device Record Key: 0b14ba1a-d2b8-4330-85b3-6b725fef5b10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuCath
• Version Model Number: PCK00009
• Catalog Number: PCK00009
• Company DUNS: 044611812
• Company Name: Bard Access Systems, 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: true
• Device Combination Product: true
• 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(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com

Device Dimensions

• Length: 2.25 Inch
• Device Size Text, specify: 0
• Length: 2.25 Inch
• Device Size Text, specify: 0
• Length: 2.25 Inch
• Device Size Text, specify: 0
• Length: 2.25 Inch
• Device Size Text, specify: 0
• Length: 2.25 Inch
• Device Size Text, specify: 0
• Length: 2.25 Inch
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741218040 [Primary]
GS1	10801741218047 [Package]; Contains: 00801741218040; Package: CA [8 Units]; In Commercial Distribution

FDA Product Code

• FOZ: Catheter, intravascular, therapeutic, short-term less than 30 days

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2020-11-09

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• 10801741231275 - CentroVena One: 2026-02-02 CentroVena One™ Insertion System Central Venous Catheter
• 10801741231282 - CentroVena One: 2026-02-02 CentroVena One™ Insertion System Central Venous Catheter