AccuCath Ace AC1181252

GUDID 10801741137973

AccuCath ACE 18G 1.25”, Intermediate Kit

Bard Access Systems, Inc.

Peripheral vascular 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 Peripheral vascular intervention infusion catheter

• Primary Device ID: 10801741137973
• NIH Device Record Key: ce485fdd-0169-40ff-a00c-f0fde5cc7bb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuCath Ace
• Version Model Number: AC1181252
• Catalog Number: AC1181252
• 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
• Phone: +1(800)545-0890
• Email: medical.services@crbard.com

Device Dimensions

• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741137976 [Primary]
GS1	10801741137973 [Package]; Contains: 00801741137976; Package: CA [10 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-03-20
• Device Publish Date: 2020-03-12

On-Brand Devices [AccuCath Ace]

• 20801741137956: AccuCath ACE 20G 2.25”, Basic Kit
• 20801741137949: AccuCath ACE 18G 2.25”, Basic Kit
• 10801741137935: AccuCath ACE 22G 1.25”, Basic Kit
• 10801741137928: AccuCath ACE 20G 1.25”, Basic Kit
• 10801741137911: AccuCath ACE 18G 1.25”, Basic Kit
• 10801741138017: AccuCath ACE 20G 2.25”, Intermediate Kit
• 10801741138000: AccuCath ACE 18G 2.25”, Intermediate Kit
• 10801741137997: AccuCath ACE 22G 1.25”, Intermediate Kit
• 10801741137973: AccuCath ACE 18G 1.25”, Intermediate Kit
• 10801741137980: AccuCath ACE 20G 1.25”, Intermediate Kit
• 10801741223690: Catheter Placement Kit
• 10801741218085: AccuCath ACE with CUE 20G 2.25”, Intermediate Kit
• 10801741218078: AccuCath ACE with CUE 20G 2.25”, Basic Kit
• 10801741218061: AccuCath ACE with CUE 18G 2.25”, Intermediate Kit
• 20801741218051: AccuCath ACE with CUE 18G 2.25”, Basic Kit
• 10801741226844: Catheter Placement Kit