AccessGUDID - DEVICE: DOSI-FUSER (08436020761867)

GUDID

Device Identifier (DI) Information

Brand Name: DOSI-FUSER
Version or Model: L25915-065D1-USA
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: EPIC INTERNATIONAL(THAILAND) COMPANY LIMITED

Primary DI Number: 08436020761867
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 662213220 *Terms of Use

Device Description: Elastomeric Infusion Pump

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?
46542	Elastomeric infusion pump system	An assembly of devices that provides continuous and/or intermittent percutaneous infusion of a prescribed medicated solution to a patient through forces from elastic material. It typically consists of an elastomeric chamber (various sizes predetermine the flow and volume) that is filled with the solution using a dedicated filling device and/or syringe to create a pressure, tubing, particulate/air-eliminating filter, a flow restrictor, and a connector at the distal end for connection to the patient's access device. It may be used for general infusion, antibiotic delivery, chemotherapy, or pain management in either a healthcare facility or in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEB	Pump, Infusion, Elastomeric

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040752	000

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 0 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 65 Milliliter

Device Record Status

Public Device Record Key: 86800b95-06e6-4d59-9ce9-b88f6f28b52f
Public Version Date: May 23, 2025
Public Version Number: 5
DI Record Publish Date: August 24, 2016