AccessGUDID - DEVICE: ISolate® Stock Solution (00857515006016)

GUDID

Device Identifier (DI) Information

Brand Name: ISolate® Stock Solution
Version or Model: 99275-500ML
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 99275
Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.

Primary DI Number: 00857515006016
Issuing Agency: GS1
Commercial Distribution End Date: April 30, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 057475246 *Terms of Use

Device Description: ISolate® Stock Solution

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:	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?
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
MQL	Media, Reproductive

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 500 Milliliter

Device Record Status

Public Device Record Key: 40dd0210-da3b-4358-8022-d57784df8b13
Public Version Date: June 16, 2025
Public Version Number: 7
DI Record Publish Date: September 10, 2016