ORION

GUDID B150302954

100ML STERILE WATER SCREW TOP

NURSE ASSIST, INC.

Device-irrigation sterile water

• Primary Device ID: B150302954
• NIH Device Record Key: 85f49dda-c7b0-498b-9f35-58610f8a8f33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORION
• Version Model Number: 30295
• Company DUNS: 869434464
• Company Name: NURSE ASSIST, INC.
• Device Count: 48
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B150302950 [Unit of Use]
HIBCC	B150302954 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901079

FDA Product Code

• BTO: Tube, Tracheostomy (W/Wo Connector)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [ORION]

• B150302964: 100ML STERILE SALINE SCREW TOP
• B150302954: 100ML STERILE WATER SCREW TOP