AccessGUDID - DEVICE: 7% PVP Solution with HSA (00893727002163)

GUDID

Device Identifier (DI) Information

Brand Name: 7% PVP Solution with HSA
Version or Model: 90121-5X0.5mL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90121
Company Name: FUJIFILM IRVINE SCIENTIFIC, INC.

Primary DI Number: 00893727002163
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 057475246 *Terms of Use

Device Description: Polyvinylpyrrolidone (PVP) Solution with HSA - 7%

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:	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?
46553	Assisted reproduction microtool	A dedicated pipette or other device used in the laboratory to denude, micromanipulate, hold, or transfer human gametes or embryos for assisted hatching, intracytoplasmic sperm injection (ICSI), or other assisted reproduction methods. 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: 0.5 Milliliter

Device Record Status

Public Device Record Key: 66f2cabb-30d7-4515-b9ad-f0f10ad78da1
Public Version Date: June 16, 2025
Public Version Number: 5
DI Record Publish Date: September 10, 2016