OmniLab Direct

Basic Information

• Brand Name: OmniLab Direct
• Primary DI: 00606959038752
• Version / Model: 2.11
• Catalog Number: 1112033
• Company Name: Respironics, Inc.
• Labeler DUNS: 080728314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 42458d1d-7022-4156-9c9d-60708f4eff9b
• Distribution End Date: 9999-12-31

Device Description

OmniLab Direct

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: No
• Has Lot/Batch Number: Yes
• 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
MNS	VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14359	Ventilator IMV controller	An unit that, added to a ventilator otherwise incapable of providing intermittent mandatory ventilation (IMV) or synchronized intermittent mandatory ventilation (SIMV) functions, permits the ventilator to provide this kind of breathing mode to the patient during his/her attempts at spontaneous breathing.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00606959038752	GS1

Customer Contacts

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