AccessGUDID - DEVICE: K-Systems (05060554120307)

GUDID

Device Identifier (DI) Information

Brand Name: K-Systems
Version or Model: G210 InviCell US Incubator
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K61500
Company Name: RESEARCH INSTRUMENTS LIMITED

Primary DI Number: 05060554120307
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 536139413 *Terms of Use

Device Description: Assisted Reproduction Accessories

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?
44290	Assisted reproduction heater/incubator	An electrically-powered device intended to provide suitable warming and/or incubation conditions for reproductive biological materials (e.g., gametes and embryos), at closely regulated and monitored temperatures, during assisted reproduction examination and processing procedures. It may support a more comprehensive growth environment [e.g., temperature, carbon dioxide (CO2) and oxygen (O2) concentration]; it typically has adjustment and monitoring controls.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUB	Accessory, Assisted Reproduction, Exempt

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
Special Storage Condition, Specify: Humidity 5%-75% RH Non condensing. Max 1 week at 50C/122F.
Storage Environment Temperature: between -5 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 49ce8761-7eac-4ec0-980e-6bd8e82c2a79
Public Version Date: February 28, 2024
Public Version Number: 2
DI Record Publish Date: March 19, 2019