AccessGUDID - DEVICE: Male-FactorPakTM (00862242000336)

GUDID

Device Identifier (DI) Information

Brand Name: Male-FactorPakTM
Version or Model: MFP-130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MFP-130
Company Name: APEX MEDICAL TECHNOLOGIES, INC.

Primary DI Number: 00862242000336
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154115885 *Terms of Use

Device Description: Specimen Collection Container used to collect semen.

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):	No
Over the Counter (OTC):	Yes
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?
63772	Semen specimen collection container	A sterile, covered, plastic receptacle intended to be used for the collection, preservation, and/or transport of a semen specimen intended for diagnostic and/or therapeutic use including, but not limited to, semen analysis, intrauterine insemination, in vitro fertilization (IVF), and/or intracytoplasmic sperm injection (ICSI). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIS	Condom

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K954791	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: less than 38 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f1601c15-27a8-4bd5-a780-d4fa4c1dbf73
Public Version Date: September 13, 2024
Public Version Number: 1
DI Record Publish Date: September 05, 2024