GUARDIVA FP-23-AD008

GUDID 10801741085816

GUARDIVA 1IN/ 4MM STERILE

Bard Access Systems, Inc.

Percutaneous catheter protector, professional

• Primary Device ID: 10801741085816
• NIH Device Record Key: 00713860-c2a8-4b94-b5b2-1c6f7a6ac9e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GUARDIVA
• Version Model Number: FP-23-AD008
• Catalog Number: FP-23-AD008
• Company DUNS: 044611812
• Company Name: Bard Access Systems, Inc.
• Device Count: 10
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 25 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 25 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 25 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 25 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 25 Millimeter
• Lumen/Inner Diameter: 4 Millimeter
• Outer Diameter: 25 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741085819 [Unit of Use]
GS1	10801741085816 [Primary]
GS1	20801741085813 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• FRO: Dressing, wound, drug

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: 2025-08-07
• Device Publish Date: 2023-11-09

On-Brand Devices [GUARDIVA]

• 10801741085823: GUARDIVA 1IN/ 7MM STERILE
• 20801741085813: GUARDIVA 1IN/ 4MM STERILE
• 10801741085809: GUARDIVA 1IN/ 1-1/2MM STERILE
• 10801741085816: GUARDIVA 1IN/ 4MM STERILE