AccessGUDID - DEVICE: ROTANTA 460 RF (04050674078160)

GUDID

Device Identifier (DI) Information

Brand Name: ROTANTA 460 RF
Version or Model: ROTANTA 460 RF - 100V-127V/50-60Hz
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5675-01
Company Name: Andreas Hettich GmbH & Co. KG

Primary DI Number: 04050674078160
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316403245 *Terms of Use

Device Description: Floor standing centrifuge, refrigerated

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):	Yes
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?
15117	Low-speed floor centrifuge, refrigerated	A freestanding mains electricity (AC-powered) device used mainly in the clinical laboratory to process through low-speed centrifugal force (typically up to 10,000 rpm) a large volume of clinical specimens (e.g., body fluids, reagents) at cool temperatures. It is typically a large stationary structure with an electric motor, a shaft, a tachometer, and speed and time controls; it also includes a rotor for mounting one of several interchangeable heads with slots to fit tubes and other sample holders, and a compressor to keep the rotor chamber cool. The device helps to control the temperature in temperature-sensitive laboratory assays such as some enzyme and complement tests.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KSO	Centrifuge, Blood-Bank For In Vitro Diagnostic Use

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: fa01a3d9-acfc-41e7-9251-6ae50e0e592d
Public Version Date: September 10, 2021
Public Version Number: 1
DI Record Publish Date: September 02, 2021