AccessGUDID - DEVICE: Nidacon (07350025610078)

GUDID

Device Identifier (DI) Information

Brand Name: Nidacon
Version or Model: PureSperm® Wash
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PSW-100
Company Name: Nidacon International AB

Primary DI Number: 07350025610078
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 631825841 *Terms of Use

Device Description: The product is intended to be used as an accessory for the separation and purification of human spermatozoa by density gradient centrifugation of human semen samples, where the prepared sperm are used for IntraUterine Insemination (IUI) and for the treatment of involuntary infertility by utilizing one of the Assisted Reproductive Technologies

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:	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?
59858	Spermatozoa/semen motility medium supplement	A sterile supplemental solution intended to be added to the medium during semen preparation for use in assisted reproduction technique (ART) procedures so as to enhance semen fluidity and sperm motility. 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 [?]
K002630	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 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 37195e63-8652-44c8-bd8e-32636ba559db
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 15, 2017