AccuCath PCK00009

GUDID 10801741218047

Catheter Placement Kit

Bard Access Systems, Inc.

Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter 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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• 00801741081538 - STATLOCK: 2023-12-21 StatLock® Stabilization Device (CV Plus,Butterfly Tricot Pad,Sliding Post Retainer)
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