AccessGUDID - DEVICE: FertiCult High Viscosity Oil (05411967000500)

GUDID

Device Identifier (DI) Information

Brand Name: FertiCult High Viscosity Oil
Version or Model: HVOIL500P
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Fertipro NV

Primary DI Number: 05411967000500
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 373904101 *Terms of Use

Device Description: FertiCult High Viscosity Oil - HVOIL500P (500ml in PETG bottle) is pre-washed with water, ready to use, high viscosity mineral oil (d=0.86-0.88g/ml) for use in In Vitro Fertilization (IVF), Intracytoplasmatic Sperm Injection (ICSI) and Assisted reproductive technologies (ART). For the latest version of the instructions for use and MSDS, visit our product page on the FertiPro website (www.fertipro.com).

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":	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?
44046	IVF medium	A solution that provides a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solution typically contains various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QKI	Media, Reproductive, Exempt

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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 Temperature: between 15 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep away from (sun)light and avoid exposure to sources of irradiation

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 500 Milliliter

Device Record Status

Public Device Record Key: ac355934-7a2e-4220-8fa3-e6c72c537d26
Public Version Date: March 08, 2023
Public Version Number: 1
DI Record Publish Date: February 28, 2023