AccessGUDID - DEVICE: LW Scientific, Inc. (00664816001905)

GUDID

Device Identifier (DI) Information

Brand Name: LW Scientific, Inc.
Version or Model: RTL-PLV4-48B1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RTL-PLV4-48B1
Company Name: LW SCIENTIFIC, INC.

Primary DI Number: 00664816001905
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 785335381 *Terms of Use

Device Description: Platelet Rotator 48 Bag

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?
43845	Basic laboratory mixer	A mains electricity (AC-powered) electromechanical device intended to be used in the clinical laboratory to mix two or more materials with a slow stirring/blending motion.	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: 3b58bbb9-19ec-4601-8e29-a9152904db4a
Public Version Date: April 19, 2021
Public Version Number: 1
DI Record Publish Date: April 09, 2021