NA

Basic Information

• Brand Name: NA
• Primary DI: 00840682103671
• Version / Model: Pedi-lite sensor, disposable, Pediatric
• Company Name: GE Healthcare Finland Oy
• Labeler DUNS: 401966697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-15
• Public Version: 9
• Public Version Date: 2022-08-05
• Public Version Status: Update
• Public Device Record Key: 8758793c-03bd-45a5-9532-92545f9a183b

Device Description

PEDI-LITE+ SENSOR, DISPOSABLE, PEDIATRIC

Device Characteristics

• Single Use: Yes
• 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
NHO	Analyzer, gas, desflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CBR	ANALYZER, GAS, NITROUS-OXIDE, GASEOUS PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1700	2
CAP	MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)	Anesthesiology	868.2600	2
BZK	Spirometer, monitoring (w/wo alarm)	Anesthesiology	868.1850	2
NHQ	Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
NHP	Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CBS	ANALYZER, GAS, HALOTHANE, GASEOUS-PHASE (ANESTHETIC CONC.)	Anesthesiology	868.1620	2
BZL	COMPUTER, OXYGEN-UPTAKE	Anesthesiology	868.1730	2
CBQ	ANALYZER, GAS, ENFLURANE, GASEOUS-PHASE (ANESTHETIC CONCENTRATION)	Anesthesiology	868.1500	2
CCL	ANALYZER, GAS, OXYGEN, GASEOUS-PHASE	Anesthesiology	868.1720	2
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
Primary	00840682103671	GS1
Package	20840682103675	GS1		50	In Commercial Distribution

Customer Contacts

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