AccessGUDID - DEVICE: SAGE Vitrification Warming Kit (60888937830486)

GUDID

Device Identifier (DI) Information

Brand Name: SAGE Vitrification Warming Kit
Version or Model: ART-8031
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Origio A/S

Primary DI Number: 60888937830486
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 305424269 *Terms of Use

Device Description: SAGE Vitrification Warming Kit, ART-8031 (in plastic cryo vials): 2x2 ml of 1,0 M ART-8031-A Sucrose Warming Solution. 2x2 ml of 0,5 M ART-8031-B Sucrose Warming Solution. 2x2 ml of ART-8031-C MOPS Solution.

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?
42850	IVF medium kit	A collection of solutions used to provide a physiological environment for the retrieval, culture, maintenance, transfer, and/or storage of human sperm, harvested oocytes (eggs), and/or resulting embryos associated with the method of in vitro fertilization (IVF). The solutions typically contain various combinations of salts, carbohydrates, amino acids, enzymes, hormones, albumin, vitamins, and/or drugs (e.g., antibiotics). Some included solutions may indirectly support the IVF process. 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 [?]
K170560	000
K173731	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 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d3434c03-0590-4a4f-b338-963210a9f969
Public Version Date: July 31, 2023
Public Version Number: 4
DI Record Publish Date: May 31, 2017