BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

CO2 Airway Adapter

DI: 20884838072170 · Model: Single-Patient use Adult Airway Adapter · Philips Medizin Systeme Böblingen GmbH

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

10

Basic Information

Brand Name: CO2 Airway Adapter
Primary DI: 20884838072170
Version / Model: Single-Patient use Adult Airway Adapter
Catalog Number: 989803142661
Company Name: Philips Medizin Systeme Böblingen GmbH
Labeler DUNS: 314101143
Distribution Status: In Commercial Distribution
Device Count in Pkg: 10
Record Status: Published
Publish Date: 2016-11-04
Public Version: 8
Public Version Date: 2023-05-05
Public Version Status: Update
Public Device Record Key: 714079b9-2594-4b1f-bc48-69e49e0db0c9

Device Description

Single-Patient use Adult Airway Adapter

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: No
MRI Safety: MR Unsafe
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
MHX	MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)	Cardiovascular	870.1025	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
Primary	20884838072170	GS1
Unit of Use	00884838072176	GS1

Customer Contacts

Phone: +1(999)999-9999
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: -20 – 60 Degrees Celsius
Type: Storage Environment Temperature
Temperature Range: -4 – 140 Degrees Fahrenheit
Type: Storage Environment Atmospheric Pressure
Temperature Range: 57 – 106 KiloPascal
Type: Storage Environment Humidity
Temperature Range: 15 – 90 Percent (%) Relative Humidity