Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10888277660182
• Version / Model: HCSCO2P
• Catalog Number: HCSCO2P
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-01
• Public Version: 1
• Public Version Date: 2021-10-11
• Public Version Status: New
• Public Device Record Key: e135e191-52da-4599-94d4-2e46382759aa

Device Description

DBD-DETECTOR,CO2,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: 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: Yes
• 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
CCK	ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE	Anesthesiology	868.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12719	Ultrasonic nebulizing system	An assembly of devices designed to generate aerosolized medication/fluids (finely dispersed airborne droplets) for inhalation by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It typically consists of a mains electricity (AC-powered) electronic oscillator, an ultrasound transducer (piezoelectric crystal), a coupling basin, a nebulizer chamber and a fan. A high frequency (e.g., 1-2 MHz) electrical current is applied to the crystal within the oscillator circuit converting it to vibrations which produce sound waves. The coupler (water or saline) transmits the sound waves to the medicated solution in the nebulizing chamber.	No	Obsolete
57824	Resuscitator face mask, single-use	A non-sterile, flexible, form-shaped device that is placed over a patient's nose and mouth to direct ambient air, or medical oxygen (O2) and air, from a resuscitator to the upper airway and lungs. It is typically made of non-conductive sterilizable materials (e.g., silicone) that will create a gastight seal against the face. It will typically include a 15 mm and/or 22 mm connector and is available in a range of sizes (baby to adult). It will be directly attached to the resuscitator and held in place on the patient's face by the operator. This device is intended for use with a breathing resuscitator but may be used for the delivery of anaesthesia gases. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20888277660189	GS1	CASE	10	In Commercial Distribution
Primary	10888277660182	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K072220	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry. Protect from freezing. Avoid Excessive Heat.
• Type: Storage Environment Temperature
• Temperature Range: 8 – 15 Degrees Celsius