AccessGUDID - DEVICE: Sperm Maintenance Medium (00857515006061)

GUDID

Device Identifier (DI) Information

Brand Name: Sperm Maintenance Medium
Version or Model: 99176-12X5ML
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 99176
Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.

Primary DI Number: 00857515006061
Issuing Agency: GS1
Commercial Distribution End Date: August 06, 2020
Device Count: 12
Labeler D-U-N-S® Number*: 057475246 *Terms of Use

Device Description: Sperm Maintenance Medium

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:	Yes
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 [?]
K991337	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
Special Storage Condition, Specify: Store Below -10°C
Storage Environment Temperature: less than -10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 5 Milliliter

Device Record Status

Public Device Record Key: 8a342a93-1f46-4b5d-9b42-1d2a90a24c98
Public Version Date: August 06, 2020
Public Version Number: 6
DI Record Publish Date: September 10, 2016