AccessGUDID - DEVICE: VersaPump Infuser (00817708023404)

GUDID

Device Identifier (DI) Information

Brand Name: VersaPump Infuser
Version or Model: FP-0010209
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FP-0010209
Company Name: EMED TECHNOLOGIES CORPORATION

Primary DI Number: 00817708023404
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622637544 *Terms of Use

Device Description: The VersaPump Infuser is a reusable mechanical, non-electronic infusion pump that does not require batteries or any electrical source. There are no alarms or displays. The VersaPump Infuser uses a spring as a source of energy to provide pressure for the subcutaneous infusion of the indicated human plasma-derived immunoglobulin solutions. The VersaPump Infuser is provided with a carrying case and User Manual. The carrying case allows the user to strap the VersaPump to their shoulder and walk around their environment during an infusion cycle. The VersaPump enclosure is made of synthetic polymer blend of glass reinforced polyphenylene ether and polystyrene, the spring is a 301 stainless steel spring, and the spring enclosure is made of synthetic polymer polyoxymethylene (POM/acetal).

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:	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?
46845	Ambulatory non-insulin infusion pump, mechanical, reusable	A non-electric, mechanically-powered (e.g., a spring mechanism) device designed for the continuous or intermittent infusion of medication, typically for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA) by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It is primarily designed to be worn by the patient during ambulation in the home. It may include flow and fluid level mechanical indicators and may be worn by the patient within and outside healthcare settings. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PKP	Immunoglobulin G (Igg) Infusion System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230883	000

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 Temperature: between -5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 110cb5b7-2e69-4555-9859-4667dff47898
Public Version Date: December 26, 2023
Public Version Number: 1
DI Record Publish Date: December 18, 2023