SPIRO

Basic Information

• Brand Name: SPIRO
• Primary DI: 07350061231046
• Version / Model: 703
• Catalog Number: 703-2K
• 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: 2023-09-29
• Public Version Status: Update
• Public Device Record Key: f3b73c37-acfc-41f2-96dc-1e3818b0fb2c

Device Description

Shower Protector for SPIRO model # 702 Humidifier

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: Yes
• 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
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	868.5375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41189	Heat/moisture exchanger, reusable	A canister-like device that, when used together with a dedicated humidifying insertable filter, connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube] to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07350061231046	GS1
Package	07350061231053	GS1	Zip-Lock Bag	5	In Commercial Distribution
Unit of Use	07350061231305	GS1
Package	07350061230223	GS1	Paper Carton	2	In Commercial Distribution

Customer Contacts

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

Storage Conditions

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