Li Ion Battery, Ventilation, Japan

Basic Information

• Brand Name: Li Ion Battery, Ventilation, Japan
• Primary DI: 00606959033344
• Version / Model: 00
• Catalog Number: 1126945
• Company Name: Respironics, Inc.
• Labeler DUNS: 080728314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-05
• Public Version: 3
• Public Version Date: 2023-05-03
• Public Version Status: Update
• Public Device Record Key: 6c12b7d5-f19d-4a89-bae9-160166e27647

Device Description

Li Ion Battery, Ventilation, rechargable battery pack, Japan

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MNT	Ventilator, continuous, minimal ventilatory support, facility use	Anesthesiology	868.5895	2
MNS	VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING	Anesthesiology	868.5895	2
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)	Anesthesiology	868.5905	2
CBK	VENTILATOR, CONTINUOUS, FACILITY USE	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36534	Portable/mobile rechargeable battery pack	A group of rechargeable batteries held within a holder, container, or mobile cart/trolley intended to provide temporary electrical energy to operate a medical device, typically when it is not possible, intentional, or convenient to connect the device being powered to a mains electricity (AC-powered) electrical outlet; it might additionally have features to facilitate transport of the device being powered (e.g., push handles, storage shelves, mounting rails). It is typically used during a transport situation (e.g., a neonatal incubator) or to power a cordless device (e.g., an endoscopic device or a rechargeable battery-powered surgical drilling system handpiece). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00606959033344	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -4 – 140 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 15 – 95 Percent (%) Relative Humidity