AccessGUDID - DEVICE: Fisherbrand (00613647024577)

GUDID

Device Identifier (DI) Information

Brand Name: Fisherbrand
Version or Model: FSSWB15
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FSSWB15
Company Name: FISHER SCIENTIFIC COMPANY L.L.C.

Primary DI Number: 00613647024577
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004321519 *Terms of Use

Device Description: ISOTEMP 15L SHAKING 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?
16772	Laboratory water bath/shaker	A mains electricity (AC-powered) device designed with a heating element, thermostat and an automated shaking mechanism to heat and shake its contents (i.e., the water and objects placed therein, e.g., bottles containing cultures or trays of gel). This device has an eccentic agitation arm that rotates at speed ranges of, e.g., 25 - 400 revolutions per minute (rpm) to create the agitation. It may incorporate a range of features such as automatic water replenishment, heating and/or cooling, automatic motion acceleration to avoid unwanted splashing.	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: 59c08078-6905-4f27-9ea5-1731b2067c1c
Public Version Date: September 29, 2022
Public Version Number: 1
DI Record Publish Date: September 21, 2022