AccessGUDID - DEVICE: Modified Ham's F-10 with Albumin (00893727002934)

GUDID

Device Identifier (DI) Information

Brand Name: Modified Ham's F-10 with Albumin
Version or Model: 99109-12X12ML
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 99109
Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.

Primary DI Number: 00893727002934
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 12
Labeler D-U-N-S® Number*: 057475246 *Terms of Use

Device Description: Modified Ham's F-10 w/Albumin

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
HDR	Cap, Cervical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K991420	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 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 12 Milliliter

Device Record Status

Public Device Record Key: 4f85a83b-d206-4788-8746-1824db22c4f9
Public Version Date: February 12, 2024
Public Version Number: 5
DI Record Publish Date: September 10, 2016