AccessGUDID - DEVICE: On-body Infusor for Furoscix® (00371767000009)

GUDID

Device Identifier (DI) Information

Brand Name: On-body Infusor for Furoscix®
Version or Model: DWG-0189
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Scpharmaceuticals Inc.

Primary DI Number: 00371767000009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079386513 *Terms of Use

Device Description: A wearable, single-use, electromechanical (battery powered, micro-processor controlled), on-body delivery system that is pre-programmed to deliver 80 mg of FUROSCIX over 5-hours using a bi-phasic delivery profile.

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:	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?
61514	Ambulatory non-insulin infusion pump, electronic	A battery-powered ambulatory device intended to provide continuous or intermittent administration of medication, commonly for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA); it is not dedicated to insulin infusion. It consists of a small unit with a pumping mechanism and an infusion-rate controller. It is used with a dedicated single-use medication cartridge and/or an injection/infusion set for delivery via an intravenous, subcutaneous, arterial, epidural or intracavital route. It is typically worn in a case attached to the belt, carried in a pocket or bag, for ambulation within and outside healthcare settings; it may be designed for optional pole mounting.	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: Yes
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
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 116 Millimeter
Width: 61 Millimeter
Height: 30 Millimeter

Device Record Status

Public Device Record Key: 09c7ff39-9242-4904-b30b-53edc3fc08e3
Public Version Date: August 07, 2024
Public Version Number: 3
DI Record Publish Date: September 21, 2023