Water Trap

Basic Information

• Brand Name: Water Trap
• Primary DI: 04719872104124
• Version / Model: ENT-2013
• Company Name: ENTER MEDICAL CORPORATION
• Labeler DUNS: 658833116
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-19
• Public Version: 2
• Public Version Date: 2023-09-28
• Public Version Status: Update
• Public Device Record Key: 45b9080f-e4a1-40c9-a522-1b5701fe82db

Device Description

A non-sterile device intended to be integrated within a breathing circuit

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
BYH	Drain, Tee (Water Trap)	Anesthesiology	868.5995	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41679	Breathing circuit condensate trap, single-use	A non-sterile device intended to be integrated within a breathing circuit (e.g., ventilator or respirator 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 fluid leaks when removed from the circuit; it does not include a moisture filter. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04719872104124	GS1