Caretaker4

Basic Information

• Brand Name: Caretaker4
• Primary DI: 00864609000300
• Version / Model: CT4
• Catalog Number: CT4
• Company Name: CARETAKER MEDICAL, LLC
• Labeler DUNS: 079403856
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-01
• Public Version: 4
• Public Version Date: 2023-11-03
• Public Version Status: Update
• Public Device Record Key: 8a6506b1-6219-49e0-b065-3d0f41bf1dde

Device Description

Wireless Vital Signs Monitor

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
DXN	System, measurement, blood-pressure, non-invasive	Cardiovascular	870.1130	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37474	Cosmetic micro-needling manual roller/stamp, reusable	A non-powered device containing short micro-needles designed to be manually pressed onto the skin to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin [collagen induction therapy (CIT)]. It is typically available in the form of a roller or stamp and is intended to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, or for hair loss therapy. It is intended for use in both the home and clinic. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00864609000300	GS1

Customer Contacts

• Phone: [phone] ext. 102
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 0 – 40 Degrees Celsius