NA

Basic Information

• Brand Name: NA
• Primary DI: 00840682102926
• Version / Model: Mini D-fend Water Trap, 8002174
• Company Name: GE Healthcare Finland Oy
• Labeler DUNS: 401966697
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-12
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 3be9958c-1e4a-465b-8d56-705fe2c62309

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
BZK	Spirometer, monitoring (w/wo alarm)	Anesthesiology	868.1850	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
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
NHQ	Analyzer, gas, isoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
NHP	Analyzer, gas, sevoflurane, gaseous-phase (anesthetic concentration)	Anesthesiology	868.1500	2
CCL	ANALYZER, GAS, OXYGEN, GASEOUS-PHASE	Anesthesiology	868.1720	2
CAP	MONITOR, AIRWAY PRESSURE (INCLUDES GAUGE AND/OR ALARM)	Anesthesiology	868.2600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31286	Breathing circuit condensate trap, reusable	A non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator breathing circuit) to collect the condensate which accumulates typically during heated humidification. It includes a fluid collection container with input and output connections, and may have an automatic seal to prevent the leak of fluid when removed from the circuit; it does not include a moisture filter. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20840682102920	GS1		10	In Commercial Distribution
Primary	00840682102926	GS1

Premarket Submissions

Submission Number	Supplement Number
K051092	000