Geri-Gentle

Basic Information

• Brand Name: Geri-Gentle
• Primary DI: 20369771000218
• Version / Model: 1221
• Company Name: GERI-GENTLE CORPORATION
• Labeler DUNS: 361663839
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 300
• Record Status: Published
• Publish Date: 2017-02-02
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: c04994f5-14e6-492f-a691-f0a70c6919ea

Device Description

IV ADMINISTRATION SET

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FPA	Set, Administration, Intravascular	General Hospital	880.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60540	Intravenous fluid bag spike	A small, sterile device intended to connect an intravenous (IV) fluid bag or blood bag to a fluid line to administer fluid to a patient. It consists of a plastic hollow spike at one end intended to be inserted into the IV bag port, a connector at the other end to attach to the IV line (typically via a drip chamber) and may include an additional administration port (i.e., Y-site device). It does not include a built-in drip chamber. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20369771000218	GS1
Unit of Use	10369771000214	GS1