AccessGUDID - DEVICE: Fisherbrand (00613647024508)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand
Version or Model: FSGPD02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FSGPD02
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647024508
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: ISOTEMP 2L GP BATH

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?
36754	Laboratory water bath	An electrically-powered receptacle for water designed to immerse and keep objects or products at a hot, or less frequently, cold temperature; typically the temperature can be controlled from a few degrees below or above ambient temperature to close to 100° Celsius (212° Fahrenheit). It typically consists of a corrosion-resistant (e.g., stainless steel) water container, heating elements, sensors, thermostats, and controls; some types incorporate refrigerating and/or stirring/agitating capabilities. It is used in various clinical laboratory procedures (e.g., paraffin wax-embedded tissue specimen flotation) and may supply tempered water to lab equipment via a pump.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTQ	BATH, INCUBATORS/WATER, ALL

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: e64d9837-b610-47aa-b62c-4b6ced081ec5
Public Version Date: September 18, 2023
Public Version Number: 2
DI Record Publish Date: September 21, 2022