UltiCare

Basic Information

• Brand Name: UltiCare
• Primary DI: 10357515174397
• Version / Model: 0439PL
• Company Name: ULTIMED, INC.
• Labeler DUNS: 024723541
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 6
• Public Version Date: 2021-04-09
• Public Version Status: Update
• Public Device Record Key: 57dbe80f-e518-444b-912b-d519d2b58fbe

Device Description

.3cc 31G 5/16

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
FMI	Needle, Hypodermic, Single Lumen	General Hospital	880.5570	2
FMF	Syringe, Piston	General Hospital	880.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38501	Insulin syringe/needle, basic	A sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used to administer an injection of insulin to a patient subcutaneously; a non-retractable needle is included, either attached or detached (usually capped for user protection). The syringe is typically made of plastic and silicone materials and will have plunger anti-sticking properties allowing smooth plunger movement. It can be used by healthcare personnel or patient, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20357515094395	GS1	Box	10	In Commercial Distribution
Primary	10357515174397	GS1
Package	20357515074397	GS1	UltiGuard	10	In Commercial Distribution
Unit of Use	00357515174390	GS1
Package	20357515910008	GS1	90ct-Box	9	In Commercial Distribution
Package	20357515181323	GS1	Healthy Accents Box	10	In Commercial Distribution
Package	20357515084396	GS1	Health Wise Box	10	In Commercial Distribution
Package	20357515124399	GS1	UltiGuard	10	In Commercial Distribution