EASY Grip

Basic Information

• Brand Name: EASY Grip
• Primary DI: 07540195000285
• Version / Model: 01BM3520
• Catalog Number: 01BM3520-CS
• Company Name: O-Two Medical Technologies Inc
• Labeler DUNS: 206449154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-26
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 66e63b21-1c2e-4657-a84b-43d4ee8a4d6c

Device Description

The disposable infant EASY GRIP® Bag Valve Mask Resuscitator is a reusable device for manual ventilation. It is designed for use in various clinical settings to provide respiratory support to the respiratory distressed or non-breathing INFANT patient. When used with a supplemental oxygen supply, the device may provide 100% oxygen on every squeeze of the bag. The disposable Infant EASY GRIP resuscitator comes standard with a Pressure Relief Valve set at 40 cm H2O which can be overridden by the operator.

Device Characteristics

• Single Use: Yes
• 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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	868.5915	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36086	Pulmonary resuscitator, manual, single-use	A non-sterile, hand-operated device designed to provide or assist ventilation in patients who are apnoeic or exhibit inadequate respiration. It typically employs entrained ambient air and includes a large flexible chamber that is hand-ventilated, a gas reservoir, tubing, and a connector for attachment to a mask or endotracheal (ET) tube; oxygen (O2) from an O2 source may also be connected when necessary. It is used used by emergency medical services (EMS) in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), mass casualty incidents (MCI), and is generally placed strategically throughout a hospital. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07540195000285	GS1
Package	17540195000282	GS1	Corrugated carton	12	In Commercial Distribution

Customer Contacts

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