PICC Guard

Basic Information

• Brand Name: PICC Guard
• Primary DI: B38320517205182
• Version / Model: 2
• Company Name: PICCGUARD, LLC
• Labeler DUNS: 117382745
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-09
• Public Version: 1
• Public Version Date: 2023-06-19
• Public Version Status: New
• Public Device Record Key: d59d4af4-c64f-4e95-a191-cd06825a9af0

Device Description

Tamper-Evident Catheter Access Cover

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: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PZW	Catheter Access Cover, Tamper-Resistant	General Hospital	880.5970	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64905	Intravenous catheter guard	A box-like device intended to attach to and encompass the proximal end/port of an in situ intravenous catheter to create a protective cover for the prevention of unauthorized intravenous access and/or tampering by the patient or other non-healthcare provider. It typically consists of a plastic box with a locking lid, which cannot be removed without being destroyed and providing tamper evidence. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B38320517205182	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K191195	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 100 Degrees Fahrenheit