NA

Basic Information

• Brand Name: NA
• Primary DI: 00840682103688
• Version / Model: D-lite sensor, reusable, Adult
• Company Name: GE Healthcare Finland Oy
• Labeler DUNS: 401966697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-16
• Public Version: 7
• Public Version Date: 2022-04-25
• Public Version Status: Update
• Public Device Record Key: fd32f167-9d06-48e6-8859-6bebb1a40187

Device Description

D-LITE SENSOR, REUSABLE, ADULT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
BZL	COMPUTER, OXYGEN-UPTAKE	Anesthesiology	868.1730	2
NHO	Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CAP	MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)	Anesthesiology	868.2600	2
CBQ	ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)	Anesthesiology	868.1500	2
CCL	ANALYZER, GAS, OXYGEN, GASEOUS-PHASE	Anesthesiology	868.1720	2
CBS	ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1620	2
BZK	Spirometer, monitoring (w/wo alarm)	Anesthesiology	868.1850	2
NHP	Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
NHQ	Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CBR	ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36849	Breathing circuit gas-flow sensor, reusable	A device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840682103688	GS1

Customer Contacts

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