AccessGUDID - DEVICE: LW Scientific, Inc (00664816003763)

GUDID

Device Identifier (DI) Information

Brand Name: LW Scientific, Inc
Version or Model: DBL-16PL-11DP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DBL-16PL-11DP
Company Name: LW SCIENTIFIC, INC.

Primary DI Number: 00664816003763
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785335381 *Terms of Use

Device Description: Dry bath incubator, Digital, One 12-place 15ml heat block and One 4-place 50ml heat block

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?
15105	Heating block IVD	An electrically-powered device which is primarily a heating element, with or without a thermostat, that is built into a compact block and intended to be used as a stable dry heat source to heat in vitro diagnostic specimens/laboratory materials. It is typically a stand-alone instrument, or an interchangeable component of an in vitro diagnostic instrument/analyser. It is available in various sizes to accommodate microplates of varying sizes, and may include covers to minimize evaporation from microplates.	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: 13398536-6115-4792-ba17-76d27b035f71
Public Version Date: May 04, 2023
Public Version Number: 4
DI Record Publish Date: May 31, 2020