N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00607411102059
• Version / Model: SO-2036-14
• Catalog Number: SO-2036-14
• Company Name: SALTER LABS
• Labeler DUNS: 022721133
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-11
• Public Version Status: Update
• Public Device Record Key: beb818f0-6a8b-4df4-9cfc-223c46c68670

Device Description

ADULT DIVIDED CANNULA W/ 14' O2 LINE AND 14' CO2 LINE W/ MALE LUER-LOCK CONNECTOR

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: Yes
• 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
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36307	Laser beam-blocking barrier	A dedicated device designed to provide protection, typically for healthcare personnel, from inadvertent laser radiation by attenuating, reflecting, and/or blocking laser energy. The device can be configured to cover a window, doorway or to partition an area of a room.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00607411102059	GS1
Package	10607411102070	GS1		25	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius