n/a

Basic Information

• Brand Name: n/a
• Primary DI: 00607511801128
• Version / Model: SO-1990
• Catalog Number: SO-1990
• Company Name: SALTER LABS
• Labeler DUNS: 022721133
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-30
• Public Version: 5
• Public Version Date: 2020-07-27
• Public Version Status: Update
• Public Device Record Key: 908a4ad4-6c71-4f9a-936d-f23bf5417357
• Distribution End Date: 2020-07-24

Device Description

Adult Nasal High Performance Sensor Cannula 7 1/4" Connect Tubing P/N: 29-4401 Disposable Single Patient Use Only. Note: incorrect DI, see ABM SO number for 5530-0, reference.

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: 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
MNR	VENTILATORY EFFORT RECORDER	Anesthesiology	868.2375	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35194	Respiratory apnoea monitoring system	An assembly of devices designed to detect the cessation of breathing (apnoea) in infants and adults who are at risk of respiratory failure to alert a parent or attendant of the life-threatening episode(s). It alarms primarily upon the cessation of breathing timed from the last detected breath, and may also include indirect methods of apnoea detection such as monitoring of heart rate and other physiological parameters associated with respiration. It may print-out this data. It will typically include a mains electricity (AC-powered) monitoring unit with software, patient leads, and possibly a recorder to record, display, or print data on a patient's breathing condition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10607411801126	GS1		10	Not in Commercial Distribution	2020-07-24
Primary	00607511801128	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K151874	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Adult

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 40 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: N/A