Comfort Release

Basic Information

• Brand Name: Comfort Release
• Primary DI: 00850003442457
• Version / Model: GB130
• Catalog Number: GB130
• Company Name: Global Biomedical Technologies, LLC
• Labeler DUNS: 080609342
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-01-27
• Public Version: 1
• Public Version Date: 2021-02-04
• Public Version Status: New
• Public Device Record Key: 5266a221-55ae-45cd-b01d-76d8496deb37

Device Description

IV Start Kit with Comfort Release GB110 & GB107

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• 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
LRS	I.V. Start Kit	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33963	Peripheral intravenous catheterization support kit	A collection of noninvasive devices intended to prepare and/or dress a peripheral vein intravenous (IV) access site. It typically includes devices such as a tourniquet, disinfected swabs, dressings, tape, gauze, and gloves; neither the IV access device nor pharmaceuticals are included. It may also include short tubing and/or syringe, however it is not intended to directly conduct fluids from an IV administration bag/bottle (i.e., not an IV administration set). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00850003442464	GS1		100	In Commercial Distribution
Primary	00850003442457	GS1

Customer Contacts

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