AccessGUDID - DEVICE: CO2 Inkubator C60 (04046668001641)

GUDID

Device Identifier (DI) Information

Brand Name: CO2 Inkubator C60
Version or Model: C60
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Labotect Labor-Technik Göttingen Gesellschaft mit beschränkter Haftung

Primary DI Number: 04046668001641
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317343861 *Terms of Use

Device Description: No description.

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?
35482	Aerobic laboratory incubator	A mains electricity (AC-powered) device heated by electrical currents passing through a heating block containing simple resistors (usually coils of nickel-chromium wire) for the purpose of growing microorganisms and cells that require oxygen (O2) for growth. Aerobic incubators are typically used for serology and crystallization studies, tissue culture work, paraffin wax embedding and in vitro fertilization (IVF).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTQ	Bath, Incubators/Water, All

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6a5e9c87-8722-46fe-83a0-23b05ed62232
Public Version Date: March 27, 2019
Public Version Number: 1
DI Record Publish Date: March 19, 2019