AccessGUDID - DEVICE: VYAFUSER™ (05713495000152)

GUDID

Device Identifier (DI) Information

Brand Name: VYAFUSER™
Version or Model: VYAFUSER PUMP KIT US/PR A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2089870410
Company Name: Phillips-Medisize A/S

Primary DI Number: 05713495000152
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 306047440 *Terms of Use

Device Description: The VYAFUSER™ Pump is an ambulatory infusion pump intended for the subcutaneous delivery of VYALEV

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
66485	Ambulatory syringe pump	A battery-powered ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency; it is not dedicated to insulin infusion. Sometimes referred to as a portable syringe driver, it consists of a small unit with a syringe driving mechanism. It is used with a suitable injection/infusion set for delivery of small/finite volumes via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt or carried in a pocket and may be worn by the patient within and outside healthcare settings.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRN	Pump, Infusion

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 53.3 and 106 KiloPascal
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 6.7 Inch
Width: 3 Inch
Depth: 1.3 Inch
Weight: 285 Gram

Device Record Status

Public Device Record Key: 22843d91-a8a9-4ad8-ac07-7ae0cd9cff45
Public Version Date: November 21, 2024
Public Version Number: 1
DI Record Publish Date: November 13, 2024