AccessGUDID - DEVICE: enFlow (10885403286162)

GUDID

Device Identifier (DI) Information

Brand Name: enFlow
Version or Model: 980202EU
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 980202EU
Company Name: Carefusion Corporation

Primary DI Number: 10885403286162
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 830432451 *Terms of Use

Device Description: enFlow&#8482 Disposable IV Fluid/Blood Warmer Cartridge With IV Extension Model 200

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47619	Convection blood/fluid warmer set	A collection of devices used in conjunction with a convection blood/fluid warmer to heat banked blood, blood products, and intravenous (IV) fluids to a temperature appropriate for infusion into a patient. It may consist of coiled tubing, or other design, 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LGZ	Warmer, thermal, infusion fluid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -30 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b85c08fe-d71a-4334-9281-12ac92d00249
Public Version Date: May 21, 2024
Public Version Number: 4
DI Record Publish Date: September 21, 2016