AccessGUDID - DEVICE: Vivaspin Turbo 15 (05060602430082)

GUDID

Device Identifier (DI) Information

Brand Name: Vivaspin Turbo 15
Version or Model: VS15T02IVD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SARTORIUS STEDIM LAB LIMITED

Primary DI Number: 05060602430082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 48
Labeler D-U-N-S® Number*: 345881551 *Terms of Use

Device Description: This single-use device can be used for In Vitro Diagnostic applications, it is suitable for use to concentrate or separate serum, urine, and other bodily fluids prior to further sample analysis.

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):	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?
43761	Centrifuge tube IVD	A tube intended to be used in the laboratory to contain a clinical specimen, reagent, or other material associated with in vitro diagnostic testing, for separation by centrifugation. It is designed to be placed in a centrifuge rotor for the procedure; it may also be placed in a rack for short-term storage of its contents. It is typically transparent to facilitate observation of its contents, frequently includes a cap (e.g., screw or press-fit), and may have graduations along the side. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJH	Clinical Sample Concentrator

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7d281177-7e1e-42b7-a636-2938a3ae5902
Public Version Date: December 22, 2021
Public Version Number: 2
DI Record Publish Date: August 17, 2020