AccessGUDID - DEVICE: ProTube (07640172343005)

GUDID

Device Identifier (DI) Information

Brand Name: ProTube
Version or Model: PTB
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Inpeco SA

Primary DI Number: 07640172343005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 484880690 *Terms of Use

Device Description: The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out.

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?
64981	Specimen information management system IVD	An assembly of hardware/software devices designed to manage specimen information, traceability and workflow within a laboratory environment. It typically consists of a data capture device [e.g., barcode reader or radio-frequency identification (RFID) scanner], touchscreen for data input and/or manipulation and a specimen container holder. It is intended to capture and transfer specimen information from the original specimen container to an assay container, which is subsequently fed into an analyser. The device does not perform specimen analysis, storage or data distribution functions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQP	Calculator/Data Processing Module, For Clinical 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: e40cc2db-0b0c-4568-9b68-1ef6271706b3
Public Version Date: September 21, 2020
Public Version Number: 1
DI Record Publish Date: September 11, 2020