AccessGUDID - DEVICE: TintoRetriever Digital Pressure Cooker Bundle (B502BSB70150)

GUDID

Device Identifier (DI) Information

Brand Name: TintoRetriever Digital Pressure Cooker Bundle
Version or Model: BSB 7015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 7015
Company Name: BIO SB, INC.

Primary DI Number: B502BSB70150
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: The TintoRetriever Digital Pressure Cooker is a precision-controlled heat source capable of mantaining a constant and reliable temperature while minimizing the potential for evaporation of the working solution.

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?
66288	Pressurized incubator IVD	An electrically-powered pressurized heating chamber intended to be used for the incubation of laboratory specimens for subsequent in vitro diagnostic procedures [e.g., heat-induced epitope retrieval (HIER) and deparaffinization for immunohistochemistry]. It is typically in the form of a pot, similar to a pressure cooker, with a lid and a removable inner liner, where samples are placed in a holder or tray for heating. It is programmable with dedicated software to control settings for temperature, pressure, and incubation time.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL 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: 350638e7-1e2e-436a-84c7-a5d4290ea419
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025