ECLERIS NIV HELMET

Basic Information

• Brand Name: ECLERIS NIV HELMET
• Primary DI: B366U1VNI1001
• Version / Model: R00
• Catalog Number: U1VNI1001
• Company Name: Ecleris
• Labeler DUNS: 043555079
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-30
• Public Version: 1
• Public Version Date: 2022-07-08
• Public Version Status: New
• Public Device Record Key: c4c2e4da-cf83-481f-be9a-29bb9cb8fff8

Device Description

ECLERIS NIV HELMET

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• Not Made with NRL: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FOG	Hood, Oxygen, Infant	Anesthesiology	868.5700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61655	In-line CPAP set, non-nebulizing	A portable collection of devices intended to be connected to a medical gas supply to assist non-intubated ventilation (i.e., without an artificial airway) using continuous positive airway pressure (CPAP) during spontaneous patient respiration in respiratory emergency situations and/or respiratory therapy settings. It includes an in-line/gas-line CPAP device (a small plastic unit intended to establish a gas pressure proportional to gas flow rate), a mouthpiece or face mask, and may include additional components (e.g., tubing, manometer gauge); it does not include a nebulizer. This is a single-patient, reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B366U1VNI1001	HIBCC

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 35 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Storage Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal