AccessGUDID - DEVICE: General Purpose Reagent Delayed Semen Analysis Media (00868586000285)

GUDID

Device Identifier (DI) Information

Brand Name: General Purpose Reagent Delayed Semen Analysis Media
Version or Model: PPM
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Quest Diagnostics

Primary DI Number: 00868586000285
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 189222334 *Terms of Use

Device Description: Delayed Semen Analysis Collection Cup and Pipette

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:	Yes
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?
66354	Home semen collection kit IVD	A collection of in vitro diagnostic devices and materials intended to be used by a layperson in the home to collect a semen specimen for subsequent in vitro diagnostic investigations (e.g., fertility testing). The kit typically includes a covered specimen receptacle with a preservative, a pipette, instructions for use, and/or a return packing/envelope for submission/mailing to the clinical laboratory. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PPM	General Purpose Reagent

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: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 50e1b68e-1acb-48f5-a772-f3b6ec3ccd47
Public Version Date: July 28, 2023
Public Version Number: 2
DI Record Publish Date: July 11, 2023