AccessGUDID - DEVICE: Enhance Sperm Freeze (00805360016643)

GUDID

Device Identifier (DI) Information

Brand Name: Enhance Sperm Freeze
Version or Model: 15609
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VITROLIFE INC.

Primary DI Number: 00805360016643
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 051915038 *Terms of Use

Device Description: Enhance Sperm Freeze, 20mL

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):	No
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?
52734	Red cell freezing/cryoprotectant solution IVD	A substance or reactant intended to be used for the preservation and/or cryoprotection of red blood cells during frozen storage of a clinical specimen so as to maintain their suitability for further in vitro testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQL	Media, Reproductive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030117	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ae79dc6e-698d-4c10-b180-f13b81ae90c9
Public Version Date: April 29, 2020
Public Version Number: 3
DI Record Publish Date: April 23, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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