Inline Water Trap

Basic Information

• Brand Name: Inline Water Trap
• Primary DI: 00709078002601
• Version / Model: 0221B
• Company Name: WESTMED, INC.
• Labeler DUNS: 092673953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-04-19
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d0d26c6d-aad4-4fcc-823e-d06451c580cd

Device Description

Inline Water Trap, For Oxygen Delivery (This is a component of the Composite Kit for Nationwide Home Med - Part #0837)

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: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• 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
CAW	Generator, Oxygen, Portable	Anesthesiology	868.5440	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
Primary	00709078002601	GS1

Premarket Submissions

Submission Number	Supplement Number
K954271	000