AccessGUDID - DEVICE: TintoRetriever Slide Thermometers (B502BSB70050)

GUDID

Device Identifier (DI) Information

Brand Name: TintoRetriever Slide Thermometers
Version or Model: BSB 7005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BSB 7005
Company Name: BIO SB, INC.

Primary DI Number: B502BSB70050
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102855447 *Terms of Use

Device Description: TintoRetriever Slide Thermometers are intended as a quality control tool to evaluate the temperature of Retrieval solutions, such as the Bio SB ImmunoDNA Retriever Citrate (BSB 0020 - BSB 0023) and EDTA (BSB 0030 - BSB 0033)

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?
17436	Laboratory thermometer	An electronic measuring instrument used in the laboratory to measure and establish the level of a temperature in an object, matter, or medium. It is designed for use in the laboratory for temperatures over a wide or particular range. It will have a high degree of accuracy and typically use a thermistor sensor for uptake of the measurement. It is typically used to verify that: 1) devices, e.g., water baths, heated cells or refrigerators, operate within the prescribed temperature limits; and 2) material, e.g., liquids, gases or semi-solids, have reached a desired temperature. For devices intended to measure the body temperature of patients see the appropriate GMDN code.	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: ed1e7a6a-067f-438e-8815-fbfd8ff6c8c6
Public Version Date: March 26, 2025
Public Version Number: 1
DI Record Publish Date: March 18, 2025