N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00607411005473
• Version / Model: 22GSOFT-7-25-10
• Catalog Number: 22GSOFT-7-25-10
• Company Name: SALTER LABS
• Labeler DUNS: 022721133
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-16
• Public Version: 3
• Public Version Date: 2022-03-22
• Public Version Status: Update
• Public Device Record Key: d6a5754d-b247-4a5d-a088-0c4a2d64cb32

Device Description

PATIENT KIT THIS KIT CONTAINS: (1) - #1205 Nipple Nut (6) - #16SOFT-7 Adult Nasal Cannula (1) - #2025G Oxygen Tubing, 25’, Green (1) - #1220 Oxygen Tubing Swivel Connector (2) - #851549 No Smoking Sign

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
CAT	CANNULA, NASAL, OXYGEN	Anesthesiology	868.5340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35201	Nasal oxygen cannula, basic	A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as "nasal prongs". This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10607411005470	GS1		10	In Commercial Distribution
Primary	00607411005473	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			adult