BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

COMFORTMATE FLUID WARMER DISPOSABLE

DI: M535FWS206B0 · Model: FWS-206-B · NXSTAGE MEDICAL, INC.

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: COMFORTMATE FLUID WARMER DISPOSABLE
Primary DI: M535FWS206B0
Version / Model: FWS-206-B
Company Name: NXSTAGE MEDICAL, INC.
Labeler DUNS: 088013219
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2015-09-01
Public Version: 5
Public Version Date: 2022-03-22
Public Version Status: Update
Public Device Record Key: 88c438e3-91d2-42d2-b9e9-4fd7074df820

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: Yes
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47618	Conduction blood/fluid warmer set	A collection of devices used in conjunction with a conduction blood/fluid warmer to heat banked blood, blood products, and intravenous (IV) fluids to a temperature appropriate for infusion into a patient. It consists of a pouch(es) or a flexible cassette through which blood/fluid flows from the infusion bag to the patient while being heated in-line by the warmer; clamps and a bubble trap may be included. The set is typically used in the operating room (OR) or in accident and emergency (A&E) situations when rapid infusion of several units of blood/fluid is necessary. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M535FWS206B0	HIBCC
Package	M535FWS206B5	HIBCC		24	In Commercial Distribution

Customer Contacts

Phone: 1-866-697-8243
Email: [email protected]

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 15 – 30 Degrees Celsius