CareTouch

Basic Information

• Brand Name: CareTouch
• Primary DI: M922CTSOS10100B3
• Version / Model: 1
• Catalog Number: CTSOS10
• Company Name: Carelife (usa) Inc.
• Labeler DUNS: 065756949
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-02-15
• Public Version: 2
• Public Version Date: 2023-03-01
• Public Version Status: Update
• Public Device Record Key: ff898db9-d0e6-4bd2-8978-7fa6a4ea4074

Device Description

10ml oral tip

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
KYX	Dispenser, Liquid Medication	General Hospital	880.6430	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59040	ENFit oral/enteral syringe, single-use	A manual device intended to be used for the administration of oral medication or delivery of enteral nutrition by connection to an enteral administration device. It consists of a calibrated hollow barrel (cylinder) and a moveable plunger intended to be operated by a healthcare provider or parent device. The tip is designed to mate only with enteral administration devices (i.e., ENFit) and is incompatible with Luer connectors; the device may be colour-coded to distinguish it from syringes designed to mate with infusion/injection devices. It may include appropriate accessories (e.g., cap, bottle adaptor). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M922CTSOS10100B5	HIBCC	corrugated case	6	In Commercial Distribution
Primary	M922CTSOS10100B3	HIBCC
Unit of Use	M922CTSOS10100B0	HIBCC

Customer Contacts

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