GUARDIVA

Basic Information

• Brand Name: GUARDIVA
• Primary DI: 00801741085819
• Version / Model: FP-23-AD008
• Catalog Number: FP-23-AD008
• Company Name: Bard Access Systems, Inc.
• Labeler DUNS: 044611812
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-09
• Public Version: 2
• Public Version Date: 2024-02-26
• Public Version Status: Update
• Public Device Record Key: 00713860-c2a8-4b94-b5b2-1c6f7a6ac9e8

Device Description

GUARDIVA 1IN/ 4MM STERILE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRO	Dressing, wound, drug	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
65042	Intravenous access site protector	A dressing-like device intended to cover and protect an intravenous access site to manage and help prevent complications (e.g., leakage, bleeding, infection). It is available in a variety of designs which may include a foam pad intended to absorb exudates/blood and a transparent shield that allows observation, sometimes with holes for ventilation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20801741085813	GS1	Case	10	In Commercial Distribution
Package	10801741085816	GS1	Shelfpack	10	In Commercial Distribution
Primary	00801741085819	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius