SPIRO

Basic Information

• Brand Name: SPIRO
• Primary DI: 07350061231084
• Version / Model: 707
• Catalog Number: 707-10
• Company Name: Fogless International AB
• Labeler DUNS: 356432815
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2018-03-31
• Public Version: 3
• Public Version Date: 2018-08-23
• Public Version Status: Update
• Public Device Record Key: caf93e55-f94d-4625-abd3-6c06fe07b379

Device Description

SPIRO Adapter (transparent) 13mm for SPIRO 702, 710, 710R and 711 to connect to a non ISO 15 tapered 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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JOH	Tube Tracheostomy And Tube Cuff	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36071	Tracheostomy tube speech valve	A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	07350061231091	GS1	Zip-Lock Bag	5	In Commercial Distribution
Primary	07350061231084	GS1
Unit of Use	07350061231329	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K122932	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dark and dry environment at normal indoor room temperature