Surestream

Basic Information

• Brand Name: Surestream
• Primary DI: 20884521552217
• Version / Model: 012689
• Company Name: ORIDION MEDICAL 1987 LTD.
• Labeler DUNS: 600111512
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-11-09
• Public Version: 8
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: b01c43d0-e13f-4d6d-9f77-91f8691734fe

Device Description

SMART SURELINE O2 PEDIATRIC

Device Characteristics

• Single Use: Yes
• 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: MR Safe
• 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
45566	Gas-sampling/monitoring respiratory tubing, single-use	A length of flexible noninvasive tube(s) primarily intended to be connected between a tube/mask breathing circuit connector and a respiratory gas measuring instrument [e.g., a carbon dioxide (CO2) or multi-gas analyser, manometer/pressure monitor] for gas pressure or flow monitoring and/or gas sampling; a microbial filter may be included. It is not intended for delivery of medical gas to the patient and does not include a patient mask or nasal cannula. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10884521552210	GS1	CASE	25	In Commercial Distribution
Primary	20884521552217	GS1

Customer Contacts

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